Facial tissue strengthening and tightening device and methods

ABSTRACT

A device is described that can be used quickly and accurately by surgeons to provide uniform facial tissue planes that are tunnel-free and wall-free thus optimizing face lifting, tightening, and implant delivery. The device is comprised of a shaft with a substantially planar tip further comprised of relative protrusions and energized relative recession lysing segments. Forward motion of the device precisely divides and energizes various tissue planes causing contraction, especially via the fibrous tissues. Other forms of energy and matter can be delivered down the shaft to further enhance desirable tissue modification and contraction.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/903,325, titled “Facial Tissue Strengthening and Tightening Deviceand Methods” and filed Jul. 30, 2004, incorporated herein by reference;which is a continuation-in-part of U.S. patent application Ser. No.09/749,497, titled “Face-Lifting Device” and filed Dec. 22, 2000, nowU.S. Pat. No. 6,974,450, incorporated herein by reference; which is acontinuation-in-part of U.S. patent application Ser. No. 09/475,635titled “Surgical Device for Performing Face-Lifting Using RadiofrequencyEnergy” and filed Dec. 30, 1999, now U.S. Pat. No. 6,440,121,incorporated herein by reference; and is a continuation-in-part of U.S.patent application Ser. No. 09/478,172, titled “Surgical Device forPerforming Face-Lifting Using Electromagnetic Radiation” and filed Jan.5, 2000, now U.S. Pat. No. 6,432,101, incorporated herein by reference;and is a continuation-in-part of U.S. patent application Ser. No.09/588,436, titled “Thermal Radiation Facelift Device” and filed Jun. 6,2000, now U.S. Pat. No. 6,391,023, incorporated herein by reference;which is a continuation-in-part of U.S. patent application Ser. No.09/085,948, titled “Ultrasound and Laser Face-Lift and Bulbous LysingDevice” and filed May 28, 1998, now U.S. Pat. No. 6,203,540,incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to face-lifting devices. More specifically,however, this application and those co-pending applications performface-lifting via precise uniform planar tissue separation with tissuetightening resulting from energetic alteration of the freshly dividedtissue planes. The device acts below the surface of the skin through themost minimal of incisions. The invention is the only tip configurationable to generate over 1000 cm² of wall-less undermined facial skin inunder 20 minutes using only three 1 cm long incisions. Although theinvention can dramatically and uniformly affect large subsurface areasand volumes of tissue, the use of the device would be considered asminimally invasive cosmetic surgery since the clinically visibleincisions are relatively small and the recovery period relatively rapid.The invention also pertains to attendant methods for enhancing theenergetic effects of the divided tissue planes via concurrentapplication of organic and inorganic, chemicals and materials. The goalof this application and related applications is to, with minimalinvasion and complete epidermal avoidance, efficiently and uniformlyseparate and divide human tissue planes without leaving remnant fibroustissue tunnels, to concomitantly coagulate distant unseen blood vessels,and to energetically alter tissues on either side of the divided tissueplanes, to induce tissue contraction and strengthening via collagenformation. Additionally, a unique and important side-benefit of thecomplete and efficient separation of human facial tissue planes (withoutleaving remnant fibrous tissue tunnels) is to interfere with thereformation of targeted wrinkles, undulations, folds or defects in thesurface tissues of the face via undercutting their deep fibrousattachments.

2. Description of Related Art

Animal and human skin is usually composed of at least 3 layers. Theselayers include the (i) outermost surface epidermis which containspigment cells and pores, (ii) dermis or leather layer, and (iii)subdermis, which is usually fat, fibrous tissue or muscle. The currenttarget of most rejuvenation methods' energies is the dermis, which iscomprised mostly of fibroblast cells. Fibroblasts produce a bed ofcollagen and ground substances such as hyaluronic acid for the dermis.When a disturbance occurs in the dermis such as trauma, fibroblasts areactivated and not only produce new reparative strengthening collagen butcontract, thus tightening and sealing healing tissue. Collagen is abasic structural protein found through almost all of the human body. Itis present in under 5% of the epidermis, half of the dermis and about20% of the subcutaneous, depending upon the race, location, age andprevious trauma of the individual. Immediate collagen shrinkage isusually parallel to the axis of the individual collagen fiber, whichroughly corresponds to the direction of collagenous strands as seen whenstained and viewed microscopically. Thermal damage to collagen is likelybrought about by hydrolysis of cross-linked collagen molecules andreformation of hydrogen bonds resulting in loss of portions or all ofthe characteristic collagen triple-helix. New collagen formed as theresult of trauma and some diseases; new collagen is technically scartissue. Nonetheless, a controlled and uniform formation of scar tissuecan be medically beneficial and visually desirable as can be seen incases of previously sun-damaged women's faces following a deep chemicalpeel. Thus, the formation of new collagen in a desirable, uniform andcontrolled fashion may lead to tissue strengthening as well astightening. It has been said that in the human face, without uniformitythere is only deformity.

Currently, a need exists for a surgical device with the followingassets: 1) minimally invasive insertion—to treat the entire face andneck through only three ⅜ of an inch incisions, 2a) precisehorizontal/tangential tissue layer separation without leaving remnantfibrous (collagenous) tissue tunnels, yet preserving nerve and vessellayered networks while maintaining straight horizontal tracking to breakany and all fibrous bonds holding the dermis to deeper structures [seenon the surface as visible wrinkles, folds, crevices], 2b) cutting tipenergy application—to coagulate blood vessels located too far from theminimal incisions to be visible the naked eye since use of endoscopes iscumbersome and time-consuming, 3) direct subsurface tissue energyapplication capability to alter, induce or stimulatefibroblasts/collagen resulting in skin tightening and strengthening thuscompletely bypassing the ultra-sensitive and fragile epidermis and thusavoiding visible surface scaring and pigment loss/excess.

Applicant meets the following needs: 1) minimally invasive surgery withvery few visible surgical device entrance wounds, 2) rapid patientrecovery and healing, 3) ability to be used with tumescent anesthesia,4) complete epidermal avoidance or bypass, 5) 20 minute operating timein the face and neck to efficiently separate and divide human tissueplanes, while coagulating blood vessels, 6) concurrent ability to altertissues adjacent to the divided tissue planes thereby inducingcollagenous reformation, contraction and strengthening, 7) completebreaking and detachment of all of the fibrous binding elements betweenthe dermis and the deeper skin structures so that reformation andreattachment will not occur thus reducing the chance that targetedwrinkles, undulations, folds or defects in the surface tissues of theface will reappear following the contractile healing phase. Currently nodevice or method in the medical literature addresses all of theseconcerns simultaneously. After the insertion of simple tumescentanesthesia, a human facial procedure is estimated to take only 15minutes to perform in experienced hands, including stitching.

Cutting (in surgery), lysis (in surgery), sharp undermining and bluntundermining have been defined in applicant's prior related art. Sharpinstrument undermining is a mainstay of plastic surgery, however evenexperienced plastic surgeons performing face-lifts may, from time totime, “lose” the correct tissue plane while performing sharpundermining; even with great skill and experience, previous surgicalscarring or aberrant anatomy may thwart surgical perfection during sharpscissor or scalpel tissue dissection/undermining. Blunt underminingemploys a rounded, non-sharp tipped, instrument or even human finger tofind the path of least resistance between tissues; once the desiredplane is found by the surgeon, blunt dissection offers the benefit of areduced chance to traumatize or damage vital structures such as facialblood vessels or nerves (to facial muscles) thereby reducing the chancesfor bleeding or permanent facial paralysis. Unfortunately, bluntundermining alone between highly fibrous tissues that exists in thehuman face results in irregular tunnels with thick fibrous walls.

Disadvantages of the current face-rejuvenating techniques using LASERSare described in the aforementioned referenced patents and those ofapplicant. Current face-lifting instruments that cut with other thanmanual energy are incapable of providing a uniform wall free tissueplane during energized face-lifting dissection. Current lasers must becrudely fired from positions outside the patient to energize tissuewithin the face and cut in a very imprecise fashion (See “Manual ofTumescent Liposculpture and Laser Cosmetic Surgery” by Cook, R. C. andCook, K. K., Lippincott, Williams, and Wilkins, Philadelphia ISBN:0-7817-1987-9, 1999) using current energy assisted face-lifting methods.Currently deep dermal tissue is treated, altered or damaged with littleprecision. Complications from the aforementioned technique have beensummarized by Jacobs et al. in Dermatologic Surgery 26: 625-632, 2000.

Disadvantages of the current face-lifting techniques usingelectrosurgical devices have been defined in the referenced patents andthose of applicant.

The paper-thin layer of the skin that gives all humans their pigmentarycolor and texture is the epidermis. Unfortunately, virtually every skinrejuvenation system that has existed until now (with the exception ofinjectable skin filling compounds) and even traditional face-liftingsurgery (when cutting through the skin around the ear is considered)must pass through the epidermis to attempt to reach and treat thedermis. Damage to the epidermis and its component structures oftenresults in undesirable colorations or color losses to the skin as isseen in scarring. The prime consideration over the last decade forscientists and engineers regarding skin rejuvenation procedures is howto spare damage to the thin but critical epidermis and adjoining upperdermal layer.

This patent application will serve as the first submitted report thatsignificant trauma to a tissue plane adjacent the dermis such, as thesubcutaneous (fatty) layer, can induce the opposing overlying layer ofdermis to contract, presumably due to inflammatory mediators or cellscrossing between the planes. Additionally, the orderly and preciseformation of new collagen (neocollagenesis) in the dermis by theinvention and related patents may lead to desirable tissue strengtheningas well as tightening. As the human facial skin ages, some of thestrongest layers of tissue which plastic surgeons use to stitch-tightenthe face, the fibrous layers known as fascia or SMAS=Superficial MusculoAponeurotic System, become thinner and weaker. Disease and environmentalfactors such as diet and chemical exposure also take their toll. Variousembodiments of the invention can be passed along these layers activatingfibroblasts, increasing the amount of collagen as a result of theprecisely delivered traumatic or tissue-altering energies the deviceinflicts to the uniform tissue planes the device creates, thusthickening and strengthening the aging layers. If even furtherstrengthening is needed in the giant, precise, bloodless subsurfaceplane that the device establishes using only three minimally invasive 1cm incisions, then three minimal incisions allow for the introductioninto the face of reinforcing meshes, tethers, slings made of organicand/or inorganic materials as well as facial implants. Prolotherapyagents have never been previously described for facial tightening orstrengthening, to our knowledge, possibly because there is currently noinstrument available to precisely create uniform facial tissue planesupon which the chemical gradients' of potential prologherapy agents canact. Following applicants uniform invention-induced facial tissue planeformations, prolotherapy fluids can be injected into the minimalincisions to enhance the actions of the instant device or to cause theirown primary effect.

Externally applied Fractional Photothermolysis is distinguishable fromthis invention and related art. Fractional Photothermolysis (FP) is welldescribed in a most recent publication by Rox Anderson: “FractionalPhotothermolysis: A New Concept for Cutaneous Remodeling UsingMicroscopic Patterns of Thermal Injury” published in Lasers in Surgeryand Medicine, volume 34, pages 424-438, 2004 by Manstein D, Herron S,Tanner H, and Anderson R. Anderson states “There is an increasing demandfor an effective and safe laser treatment that repairs photo-aged skin.Two treatment modalities, ablative skin resurfacing (ASR), andnon-ablative dermal remodeling (NDR), have been developed to addressthis demand. All currently available laser treatments, however, exhibitsignificant problems and these laser systems typically operate safelyand effectively only over a narrow, patient dependent treatment range.”The prime reason for the narrow range is the ultra-delicate epidermis.Anderson advocates, “Studies indicate that the efficacy for treatment ofrhytides (wrinkles) and solar elastosis improves with increased thermaldamage depth [Anderson's reference 9]. The most effective Erbium: YAG(Yttrium Aluminum Garnet) lasers for the treatment of rhytides uselonger pulse durations to increase the residual thermal damage depth[ref 10]. To enhance wound healing without sacrificing efficacy, acombined approach has become popular for ASR [ref 11]. To overcome theproblems associated with ASR procedures, the so-called NDR technologieshave emerged that selectively damage the dermal tissue to induce a woundresponse, but avoid damage to the epidermis [refs 12-25]. In thistechnique, controlled dermal heating without epidermal damage isachieved by combination of laser treatment with properly timedsuperficial skin cooling. The wound response to thermally damaged dermaltissue results in formation of new dermal collagen and repair of tissuedefects related to photoaging. The absence of epidermal damage in NDRtechniques significantly decrease the severity and duration of treatmentrelated side effects. Lasers used for NDR procedures have a much deeperoptical penetration depth that superficially absorbed ablativeErbium:YAG and CO2 lasers. While it has been demonstrated that thesetechniques can avoid epidermal damage, the major drawback of thesetechniques is limited efficacy [ref 26]. Anderson measures and reports amere 2% tissue shrinkage results: “ . . . small but reproducible, skinshrinkage was observed as measured by microtattoo placement. Skinshrinkage was still evident 3 months following treatment.” Anderson'sconcern to minimize permanent epidermal damage, especially indarker-skinned patients, is evident “In our study, there were severaldark-skinned subjects, who demonstrated little or no significantpigmentation abnormalities after FP at low or medium MTZ (MicroscopicTreatment Zones) densities per treatment. Histology revealed that thereis a localized, well-controlled melanin release and transport mechanismusing MENDs (Micro Epidermal Necrotic Debris) as a ‘vehicle’.”

Externally applied FP as described by Anderson differs from applicant.Anderson's FP device must be placed on the external skin surface and hasnot been described for internal use to reach the outer layers of skinfrom the inside route. Anderson's FP device is external, not designedto, not can it, break the fibrous tissues beneath the surface skin andcannot be passed beneath the skin without another attachment or devicesuch as applicant's tip to “ice-break” the way. Without breaking thefibrous bonds below the skin surface that attach the surface skin to thedeeper structures of the face that bind wrinkles in permanently.Unfortunately, surface treatments are only temporary and cause onlyminor tightening. Anderson's externally applied art must restrict energydelivery, which renders only a 2% tightening in order to avoid damagingthe fragile epidermis. Anderson uses MENDs (Micro Epidermal NecroticDebris) that allow sufficient time and space for traumatic epidermalre-growth to occur to avoid permanently damaging the epidermis. Anembodiment of applicant creates MEND or even Focal Macroscopic Necrosis(FMN) and delivers energy, from inside out on uniform tissue planesallowing uniform energy gradients and therefore bypass the delicate andsensitive epidermis while still bringing about deeper tissuecontraction. Applicant's U.S. Pat. No. 6,203,540 involves laserfiberoptics which can be pulsed and delivered below the skin to bringabout FMN like lesions. Fiber sizes mentioned would provide energydestruction patterns greater in size then MEND's; however, fiberopticsize in U.S. Pat. No. 6,203,540 may be reduced to bring about damagevolumes somewhat greater than or approaching the size of MENDs anddischarge more energy ‘upward’ toward the epidermis than Anderson forgreater dermal alteration with minimized epidermal effect. Applicantallows for the treatment of a larger surface area much more rapidlybecause of the capability for greater direct, internal energy transfer.Applicant treats the entire face and neck to the collarbones in under 20minutes operating time by an experienced hand. Anderson's devicedelivers only a 2% tissue contraction measurement in tissue under nogrowing tension as compared with applicant's 20%-30% contraction in10×10 sqcm tattoo grids on the abdomens of baby pigs that doubled insize over the 3 month study period (unpublished, photographs availableupon request). The difference in results is largely due to the greatdisparity between the two methods in energy delivered to the tissues.(Underlining was added for emphasis).

Laser treated tissues and electrosurgically treated tissues are similarin several respects. However most importantly, when it comes tointernally electro-modifying human tissues, is that immediately localvaporized tissue regions take on a relatively high electrical impedance,and increase the voltage difference, thus altering further localelectrical penetration/treatment of the tissues. Irregular energyabsorption by irregularly thick and irregularly formed fibrous tunnelremnants resulting from the use of devices, other than applicant's,would thus cause visible irregular skin surface effects on healing.Other reasons why applying tissue-altering energy to precisely formedfacial tissue planes without fibrous tunnel wall remnants is importantinclude: “the electrical impedance of tissue is known to decrease withincreasing frequency due to the electrical properties of cell membraneswhich surround the electrically conductive cellular fluids. As a resultof higher tissue impedance, the current flux lines tend to penetrateless deeply resulting in a smaller depth of tissue heating. If greaterdepths of issue heating are to be effected a higher output voltage andfrequency must be used. Lower impedance paths will automatically resultin lower resistive heating since heating is proportional to theoperating current squared multiplied by impedance.”

Monopolar electrosurgical instruments possess a single active electrodeat the tip of an electrosurgical probe. Low voltage applied to theactive electrode in contact with the target tissue moves electricalcurrent through the tissue and the patient to a dispersive groundingplate or an indifferent electrode. Voltage differences between theactive electrode and the target issue cause an electrical arc to formacross the physical gap between the electrode and tissue. At the pointof arc contact with tissue, rapid tissue heating occurs due to highcurrent density between the electrode and tissue. Current density causescellular fluids to vaporize into steam yielding a cutting effect.Monopolar electrosurgery methods generally direct electric current alonga defined path from the active instrument electrode through thepatient's body into the return or grounding electrode. Small diameterelectrodes increase electrical field intensity in the locality. Bipolarconfigurations more easily control the flow of current around the activeregion of a treatment device which reduces thermal injury and thusminimizes tissue necrosis and collateral tissue damage while reducingconduction of current through the patient. Applicant believes that theoptimum combination of electrical energies to be used in conjunctionwith a protective tip is monopolar cutting current in the lysingsegments and adjunctive monopolar or bipolar coagulation current alongthe planar aspects of the device. Because of applicant's discovery thatthe highly resistive lower fatty layer plane of facial dissection may beelectrically or energetically traumatized and eventually result in thetransfer of mediators into overlying, over-draping dermis causing itscontraction (likely by inflammatory chemical mediators or cellulartransfer), logically higher energy formats than bipolar would benecessary to necrose the fatty layer for the transfer effect(subcutaneous to dermis traumatic inflammatory shrinkage transfereffect=SDTISTE) to occur.

Eggers in U.S. Pat. No. 5,871,469 and related patents differs fromapplicant. Eggers teaches an electrosurgical device that requires anionic fluid to create conduction between minute arrayed electrodes andrelies on an ionic fluid source from within the instrument to functionoptimally. Eggers teaches bipolar energy flows principally between pairsor groups of minute electrodes arranged in various arrays depending uponthe embodiment chosen. Unfortunately, observing Eggers' diagram 2c topview may lend the incorrect impression of similarity in shape to theapplicant tips; however, in Eggers the protrusions areelectrodes/conductors which would irregularly violate and destroy thevital human facial tissue structures including the subdermal plexus ofvessels on passage if creation of a plane were attempted or evenpossible. Applicant's protrusions are non-conductive or insulatedprotectors and facilitate precise device movement, wall-free uniformtissue plane formation while providing for vital subdermal plexus tissuepreservation. Eggers' embodiment of electrode arrays at the tip may belikened to component rasps of a oil well drill bit where the arrayprotrusions bite into and chew away to form a canal in the targettissue, a desired effect that is totally counter to the intentions anddynamics of applicant. To quote Eggers in U.S. Pat. No. 5,871,469 column4 line 49: “The electric field vaporizes the electrically conductiveliquid into a thin layer over at least a portion of the active electrodesurface and then ionizes the vapor layer . . . ”. Eggers teachesvaporizing a thin layer of an optimizing conducting fluid; additionalapplication of a conducting fluid is not a necessity for applicant.Eggers furthermore reveals in column 11: “The depth of necrosis (tissuedeath, lethal alteration) will typically be between 0 to 400 microns andusually 10 to 200 microns (=0.2 mm).” The energy levels that aregenerated by applicant allows tissue damage to depths of 4 mm (4,000microns) over twenty times greater than Eggers' safe range. Onlyapplicant can create tunnel free, wall free, uniform tissue planes uponwhich to apply tissue modifying energy or tissue modifying chemicals andrender uniform gradient potential. Eggers' U.S. Pat. No. 5,871,469external skin resurfacing (Visage®) requires an external ionic fluiddrip and has been in clinics and is known not to remove much more thanvery fine wrinkles without epidermal pigment changes or scarring. Onlythe thinnest wrinkles can be reduced by Visage®. Eggers fails todescribe any protrusion-recession tissue protecting energizable tip toreliably track without the formation of tunnels or remnant tunnel wallscapable of creating uniform facial tissue planes upon which to uniformlytransfer energy. Without uniform tissue planes to uniformly energize,there cannot be uniformity of tissue contraction. Without facialuniformity there is only non-uniformity.

Eggers' U.S. Pat. Nos. 6,740,079 and 6,719,754 and 6,659,106 and6,632,220 and 6,632,193 and 6,623,454 and 6,595,990 and 6,557,559 and6,557,261 and 6,514,248 and 6,482,201 and 6,461,354 and 6,461,350 arevirtually all bipolar in nature and require a fluid delivery elementthat may be located on the probes or part of a separate instrument.Alternatively, an electrically conducting gel or spray may be applied tothe target tissue. All are incapable of yielding tunnel-wall-free,completely uniform facial planes upon which to energetically actthereupon. '559B1 does teach a single platypus-bill shaped,asymmetrically located, “atraumatic” shield which is totally incapableof yielding tunnel-wall-free, completely uniform facial planes uponwhich to energetically act since a single shield would createnon-uniform tunnels and be deflected by them to a zone of leastresistance. '354B1 requires that the bipolar electrodes be maintained “adistance of 0.02 to 2 mm from the target tissue during the ablationprocess . . . maintaining this space . . . translate or rotate the probetransversely relative to the tissue (brushing)”. If coagulation orcollagen shrinkage of a deeper region of tissue is necessary (sealing animbedded blood vessel) . . . press the electrode terminal . . . Jouleanheating.” In itself, '354B1 would thus be impossible if not completelyimpractical device for use as an internal, minimally-invasive, completefacial tissue modification device because fulfilling such requirementsof pressing blindly to seal unseen blood vessels up to 10 cm away from alimited incision port would impossible without an endoscope and thustake hours to complete surgery (less than opening up and closing anentire traditional face-lift). The handling of bleeding vessels, as percolumn 8 of '350B1, is surgically awkward without an endoscope andsurgically impossible if performed blindly from limited incisions forthe same reasoning as just mentioned for '354B1. '350B1 relies on therelative weakness of the electrical energy found in bipolar designs;circuitry detection and interruption with an alarm may fail to preservenerves as opposed to applicant which relies on geometry to maintainprecise location on motion and palpable feel to manipulate away fromknown nerve locations to avoid damage. Applicant and other facialsurgeons disagree with Eggers statement in '261B2 that 150 degreeCentigrade temperatures generated by probe's residual heat can sealvessels; those who disagree cite the example medium sized branches ofthe facial artery in the event of a bleed a hidden distance fromminimally invasive incision sites. In all of Eggers, especially '193B1,FIG. 3, initial inspection of the two-dimensional figures may resemblethose of applicant, however the protrusions are in a cylindrical base,conductive, non-insulated, not linearly arranged and do not have alysing segment between them. '248B1 uses a laterally deployable andretractable antenna arising from the side of a pencil-shaped shroud-likeprobe to more precisely modify electrosurgical arcs for cutting oftissue. '248B1 differs from applicant by using a laterally basedelectrode and being unable to position said portion of the cuttinginstrument for uniform lysis of the delicate undersurface of the face.The lateral wire of '248B1 would be forced in a direction opposite theareas of greatest fibrous build-up adjacent non-uniformly lysed tunnelsthus resulting in a non-uniform result. '079B1 is an electrosurgicalgenerator capable of delivering uniform discharge arc at the tip andthus more precise cutting wave. '079B1 uses an active electrode with adynamic active surface area of varying geometry however, applicant'sgeometry differs significantly in that '079B1 is incapable of yieldingtunnel-wall free completely uniform facial planes which would adverselyeffect evenness in tissue plane energy absorption. Additionally, themonopolar cutting current of '079B1 is undesirable for collagen/fibroustissue modification function of applicant'stissue-modifying-energy-window/zone and would largely damage thedelicate underside of the facial dermis and dermal plexus since '079B1'sstated and anticipated geometry lacks the protective insulatedprotrusions of applicant to safeguard such vital structures. Virtuallyall of Eggers teaches bipolar electrosurgery; as Eggers states, bipolarelectrosurgery desirably create the following “plasma layer confines themolecular dissociation process to the surface layer to minimize damageand necrosis to the underlying tissues.” To bring about significantuniform and safe modification of the overlying dermal and epidermaltissues without irregular defects such as necrosis is not possiblewithout applicants geometry and adjacent energy function. Because ofthis lack of significant tightening efficacy without permanent epidermalchanges or scarification, Visage® has seen only limited use in cosmeticsurgery and salons; use at higher energy levels has caused undesirablesurface skin scarring.

Goble, U.S. Pat. No. 6,210,405 teaches an electrosurgical rasping devicethat works similarly to Eggers. Goble teaches a “rasping” device thatcreates vapor bubbles requiring aspiration around the targeted tissue asopposed to applicant who teaches smooth forward instrument withoutrasping to wear down target surface. Goble teaches uses in orthopedicsurgery and urological surgery requiring a saline like solution “ . . .to fill and distend the cavity . . . ” as opposed to Applicant andapplicant's prior related art which does not. Goble teaches aninstrument useful for “brushing . . . debulking . . . sculpturing andsmoothing” as opposed to applicant who cuts and passes smoothly by thetarget tissue which is not to be removed but energetically altered andleft in place to remodel. Gobel requires an ionic fluid pump and anaspirator and mentions the need for endoscopic assistance as opposed toapplicant. Applicant teaches a feel-only, blindly operated devicewherein pumps or aspirators are optional. Goble's teaches “rasping” asacting like a rasp to “wear down” as opposed to applicants prior use ofthe word “rasp” which just the feeling that the operating surgeon getswhen the device passed successfully in the proper fibro-fatty facialtissue plane.

Thermage, Inc. of Hayward, Calif. recently introduced to the market itstissue contraction product of an externally applied electrosurgicaltemplate activated while touching the outer. Energy passes through theepidermis thus passing energy through the upper skin with the intentionof electrically altering collagen to achieve remodeling; damage to theepidermis is reduced some by externally spraying a cryogen (cooling gas)of about −40° C. on the targeted zone's epidermis at the time of theelectrical impulse. Unfortunately, the amount of tissue contractionThermage, Inc. can prove in the medical literature borders uponstatistical insignificance (to quote several prominent cosmeticsurgeons) and is far less than 5%. Currently, great debate exists in thecosmetic dermatologic community as to whether a statisticallysignificant improvement exists at all regarding Thermage's tissuecontraction. U.S. Pat. No. 6,413,255B1 of Stern relates to Thermage'sdevice and is an externally applied “tissue interface surface . . . andhas a variable resistance portion.” '255B1 teaches a linear array ofexternally applied bi-polar electrodes; an externally applied monopolarembodiment using return electrodes is also illustrated. Base claims in'255B1 regarding the electrosurgical delivery device indicate contactwith the skin's external, outer surface. Knowlton U.S. Pat. Nos.6,470,216 and 6,461,378 and 6,453,202 and 6,438,424 and 6,430,446 and6,425,912 and 6,405,090 and 6,387,380 and 6,381,498 and 6,381,497 and6,337,855 and 6,377,854 and 6,350,276 and 6,311,090 and 6,241,753 and5,948,011 and 5,919,219 and 5,871,524 and 5,755,753 are Thermage, Inc.licensed. Knowlton mentions in '498B1 “the methods of the presentinvention do not provide for total necrosis of cells. Instead, . . . apartial denaturization of the collagen permitting it to becometightened.” Knowlton cites the failure of U.S. Pat. No. 5,143,063 toprotect the melanocytes (pigment cells of the epidermis) as a need “fortissue tightening without damaging the melanocytes or other epithelialcells, or without surgical intervention.” Knowlton's before-mentionedart is thus classified as non-invasive and therefore involving noincisions or intended openings even in the epidermis as a result oftissue damage. Applicant's art requires incisions as opposed to thebefore-mentioned art of Knowlton, which is not mentioned to be insertedthrough the skin; Knowlton's devices are far to large to be adapted toany minimally invasive surgical sites. '854B1 Method for ControlledContraction of Collagen in Fibrous Septae in Subcutaneous Fat is largelyviewed in the medical community to be undesirable. Pulling on the septalstrings cause in-pocketing of the surface skin. This because cellulite(an undesirable problem) is currently widely thought to be the result ofcontracted fibrous septae causing in-pocketings of the upper skin layersdown toward the fatty layer. In '753B1 Knowlton desires to create nodeeper than a second degree burn on the tissue surface to internallyscar and thus create tissue contraction over areas such as a bony callusover periosteum and states, “This method is particularly useful intissue sites that are devoid or deficient in collagen.” In '753B1Knowlton mentions that the device can be done transcutaneously,percutaneously or via endoscope, Knowlton also mentions reverse thermalgradients in that epidermal sparing results form heating below thesurface. The principle of delivering electricity on a medical instrumentunder the skin is not novel, just the use of Knowlton's specificembodiment is. Similar percutaneous delivery of energy has however longbeen the practice of surgeons dating for electrosurgery at least fromthe mid 1980's and for laser surgery from the 1990's when Cook wasdirecting lasers percutaneously to contract the underlying dermis of theneck. Much of the endoscopy art dating over one to two decades allowsfor percutaneous delivery electrosurgery and or laser. Mostdistinguishing is that '753B1 fails to provide a means to create auniform planar tissue surface upon which to deliver electronic energy ina uniform fashion. Irregular target surfaces yield irregular electronicenergy gradients. Applicant can provide a uniform band of freshlyseparated facial tissue to treat that is free of fibrous tunnel walls;thus, the overlying collagen can be uniformly treated by an underlyingenergy source and gradient without resultant striping or banding of theoverlying skin including the epidermis. '753B1 provides no means or anenablement to allow for a minimally invasive creation of a path in whichto pass the '753B1 device freely without the formation of tunnels orbreaking strong fibrous impediments. Knowlton in '276B1 displays a FIG.2A showing an “introducer” that crudely in two dimensions resemblesapplicant; however, this is merely because the cylindrical 2A devicewith protruding attachment channels for cables, catheters, guide wires,pull wires, insulated wires, optical fibers, and viewing devices/scopeshas been rendered only two-dimensionally whereas three-dimensionalconsiderations reveal great dissimilarity. Knowlton's description incolumn 4 of '276B1 mentions the device coupling to a template to receivea body structure. '276B1 apparently mentions and designs for onlyexternal tissue (or other outer layer skin like mucosa) to be in contactwith the template. The remainder of the group of patents are related to'090 and involve externally applied devices to the outer skin with ionpermeable porous membranes using electrolytic solutions that at leastpartially conform over the external skin surface in a way similar torubber ('202B1 teaches inflating a membrane for body conformation);monopolar and bipolar embodiments are presented. Such devices areintended to pass radiant energy (defined as any kind that can cause cellheating or physical destruction including RF, microwave, ultrasound,etc.) through the epidermis in a uniform fashion and to minimizeepidermal damage using cooling lumens and surface cooling fluids.Applicant and applicant's prior related art on the other hand teach aninternal probe with a special tip that provides tunnel-free planarlysing precisely through human face while maintaining a trackingfeeling. Nonetheless, following many published studies the energyapplied through the simultaneously cooled epidermis of U.S. Pat. No.'255B1 is insufficient provide a consensus on photographic wrinkle ortissue tightening improvement beyond mild. Conversely, Applicant andapplicant's prior related art teaches energy levels that are much higherin fluence and bypass the ultrasensitive epidermis altogether. Applicantand applicant's prior related art does not necessarily require a cryogenspray to reduce epidermal heating so as to pass significantly greaterlevels of electrical energy into the targeted dermis.

Brucker, U.S. Pat. No. 5,500,0012 and other spot treatment combinationenergy devices using laser, fiberoptics, radiofrequency, ultrasonic ormicrowaves differ from Applicant and applicant's prior related art intheir inherent shapes which are usually catheter like, bendable,circular in cross section. Flexible catheters cannot not penetrate thefibrous tissues of the face on their own. Such devices are usually meantto migrate between organs to perform a ‘spot’ treatment on one or moreof them. It is to be noted in FIG. 4 of Brucker that electrodes 18 & 20are detector electrodes meant to aid in the detection of electricalheart arrhythmias and that any similarity to the insulated protrudingsegments of Applicant and applicant's prior related art is clearlydifferent when two dimensional drawings are considered in threedimensions just as was Eggers'. Brucker as a bendable catheter would nothave the rigidity to course along the proper fibrous facial plane andwould simply bore a hole or tunnel or be directed in a path of leastresistance. The only similarity between Brucker and the instantapplication of Applicant and applicant's prior related art is thatBrucker may carry fluids toxic to heart cells; however, applicant's useof prolotherapy with the device is to uniformly modify a uniformlycreated tissue plane. The arrays of electrodes in Brucker are detectingelectrodes located around the tip of Brucker in which lies a singleenergized treatment electrode that only escapes or transiently protrudesfrom the catheter channel when there exists a need to kill heart cellsthat are improperly firing electrically; Brucker's protruding arrays areusually not deployed in motion and would likely interfere with motion bycatching on tissues during motion, Brucker's protrusions therefore donot aid in device motion.

Single lumen, circular or non-planar cross sectional laser deliverydevices such as Keller U.S. Pat. No. 5,445,634 & U.S. Pat. No. 5,370,642usually require the use of an accessory endoscope. An endoscope is acumbersome optical instrument that would usually requires two hands touse at the same time the surgeon is handling Keller's instrument todirect it to the target tissue which would be difficult indeed. Kellerand similar devices differ by lacking applicant's planar tipconfiguration of protective relatively protruding non-conductingelements with energized relative recessions. Applicant's art can bemanipulated blindly by the surgeon without the aid of an endoscope sincethe device provides instant continuous feedback via a simple palpable“feel” that the surgeon can easily learn and rely on for certainty thatthe device is migrating in the tissue properly. Devices such as Kellercan only perform spot tunneling unless the surgeon is also using anendoscope that focuses some type of tissue dissociating energy along anentire tissue plane; unfortunately, to maintain a coordinated planarmovement with Keller would be time-consuming and difficult. Kellerdiscusses that results using '634 and '632 are limited to channels.

Loeb of U.S. Pat. No. 5,984,915 teaches passing only a single bareoptical fiber through human facial subcutaneous skin tissue. Loebhowever does not teach any housing or rigid or semi-rigid structure thatwould allow passage of a bare optical fiber through undissected toughand fibrous human fibro-fatty facial tissue. In line 55 column 6 Loebstates and alleges: “The optical fiber is a bare optical fiber . . . .The tip pierces the skin and is advanced into the subcutaneous tissuewhile emitting laser energy . . . . ” Loeb further teaches in column 9line 14: “The diameter of the tip of the optical fiber is in the rangeof about 25-100 microns (<0.1 millimeter) . . . . Preferably about 50microns . . . . ” Those skilled in the art readily know that it isimpossible to advance such a thin fiber through relatively impenetrablehuman facial tissue to have any uniform clinical effect. Withoutuniformity on the face, one has deformity. In light of the human facialanatomy, where the dermis is composed of almost impenetrable collagenfibers close to the density of football leather and where thesubcutaneous fatty layer contains collagenous fibrous septae that arerelatively dense although not as dense as the fatty layer of abdomen,Loeb cannot deliver a uniform effect and is impractical as enable in'915. Applicant differs from Loeb because applicant provides for arelatively rigid structure housing energetic elements that can penetratethe extensive fibrous septal network of the facial subcutaneous layerand provide uniform tissue surfaces to enlarge thus altering thecollagen of this layer of the face efficiently. Loeb teaches a pulsedenergy level in Table 1 for “skin wrinkle removal”, that even if theimpossible task of passing a single hair thin optical fiber through therelatively dense facial fatty layer were possible then based upon Loeb'sfiber diameter it would take many hours to days to efficiently irradiateor treat a whole face. It is noteworthy that under most facial wrinkles,collagenous accumulations are particularly dense further arguing againstLoeb.

The term rhytisector is a compound word derived from(rhyti=wrinkle)+(sector=to cut or remove). The tool was usually insertedunder the skin in a natural crease, fold or hairline a distance from thetargeted wrinkle to be “removed”. A rhytisector is a “Y” shaped devicemade of metal with the shaft/base of the Y usually being between 8 cmand 16 cm long and the arms of the V portion of the Y being about 3-4 mmand the base (acute angle) of the rhytisector is usually thin andcutting in nature. Rhytisectors discussed in the medical literature arecompletely flat when viewed horizontally from the side and notelectrified energized in any way. Rhytisector use has decreaseddramatically over the last decade. Unfortunately, the rhytisector tooldeveloped a reputation for intense bleeding leading to bruising,hematomas (blood pools) and unwanted blood vessel laceration (breakingopen). This was largely due to the sharp edges and no ability tocoagulate. Applicant has searched catalogues from prior to 1999 of manymajor electrosurgical and plastic surgical/medical instrumentmanufacturers: Bernsco, Ellman, Colorado Biomedical, Conmed, Delasco,Snowden-Pencer, Tiemann, and Wells-Johnson and found no mention of anyrhytisector that was electrifiable or substantially electricallyresistive on the distal tips of the “Y”. Even if a rhytisector wasinsulated similar to applicant the shape would be different since therhytisector is a completely thin and equally flat instrument.

U.S. Pat. No. 5,776,092 by Farin describes a single tube device that candeliver laser, ultrasound or radio frequency devices to treat tissue.However, Farin's device is not intended for separating tissue planes andis susceptible to catching, tearing or puncturing the tissue whenmanipulated. The dissimilarities between Farin's device and thosesimilar have been described in this application and those co-pending.

The dissimilarities of using ultrasonic liposuction cannulas forface-lifting or facial tightening from this patent application have beendescribed in this application and those co-pending.

There exists a special subset of the general population that may benefituniquely from the present invention. The facial skin and substructure ofCaucasian men and women begins to droop and develop folds between theages of 45 and 55. Patients of Asian, Hispanic and African origin willexperience the same stage of this condition but at a bit later age.Currently long incisions of 10-20 cm are made around each of the twoears, for the purposes of hiding the scars; skin is cut out anddiscarded and the remaining skin stretched. Unfortunately, skin does notthicken in response to stretching and removal; it only thins. In theearly 1990's, some plastic surgeons advocated “prophylactic” or“preemptive” face-lifting on women in their 40's purportedly to “stayahead of nature.” This philosophy of “prophylactic face-lifting” has nowbeen largely discredited by the vast majority of reputable surgeons.

Given the disadvantages and deficiencies of current face-lifting andskin-tightening techniques, a need exists for a device that provides afast and safe alternative. The present invention utilizes a uniqueenergized lysing design adjacent to various similar and dissimilar formsof energy to induce tissue contraction. The present invention provides aprocess for human or animal tissue strengthening to achieveface-lifting, facial tightening, or non-facial tissue tightening. Thedevice and methods can rapidly be used in hospitals as well asoffice-based surgery and minimizes pain and risk of injury.

SUMMARY OF THE INVENTION

It is an object of the present invention is to provide a method and adevice that can be used by surgeons to provide quick and accurateface-lifting, tissue strengthening or tightening maneuvers is minimallyinvasive, rapidly performed with relatively speedy patient recoverywhile reducing pain and side effects.

It is another object of the invention to provide a surgical face-liftingdevice that easily maintains the proper dissection plane while uniformlylysing and offering the capability to deliver energy to uniform tissueplanes to induce skin tissue tightening and strengthening.

Another object of the invention is to provide an undermining device thatcan position lysing surfaces at a proper level for controlled, safe anduniform fibro-fatty tissue separation during a face-lift that istunnel-free and free of fibrous walls.

Tip shape and size definitions are as follows: bulbous—tip projection inthe rough geometric or rounded shape of a bulb when viewed from the topor front when compared with a thinner adjacent lysing area; lysingsegment—tip area that is thinned when compared with adjacent area in theshape of a bulb when viewed from the front; relative protrusion—tipprojection in the rough geometric or rounded shape when viewed from atleast one angle when compared with a thinner adjacent “lysing area” thatwould be relatively recessed; relative recession—areas of the tip thatappear recessed as opposed to the relative projections when viewed fromat least one angle.

The device is comprised of a hollow or solid shaft with a relativelyplanar tip that can be easily positioned and maintained betweendissection planes in tissue and then manipulated to uniformly separatetissue planes and completely lyse fibrous tissue. It has been shown in avery limited fashion by Cook in the medical and others in the scientificliterature that the effects of energy application to the collagenous(dermal, superficial platysma musculature and other) tissues of the facein the facelift plane can cause contraction and tightening. Accordingly,the invention also provides an energy source and delivering means, whichdelivers energy to the distal end of the shaft. Many forms of energy maybe used to energize various portions of the device includingmulti-chromatic light, monochromatic light, laser light, radio frequencyelectrical energy, vibrational energy, ultrasonic energy, microwaveenergy, thermal energies both hot and cold, chemical energy or anycombination thereof. Applicant can transmit significant energy to thesubcutaneous tissue whereby the inflammation and mediators created crossthe separated plane into the overlying dermis causing inflammation andcontraction.

The preferred embodiment of the invention has a plurality of protrudingmembers on the distal end of the shaft, referred to herein synonymouslyas tip, separated by at least one interstitial lysing segment, whereinthe lysing segment is recessed relative to the protruding members. Aplanar, round or geometric shaft may terminate in some geometry of tipthat is nonetheless substantially planar within a rectangle, somewhatcurviform or geometric but somewhat off-plane. The tip shape when seenfrom above or below may vary and be rounded, squared, rectangular,serrated, scalloped, grooved, or geometric. Curved and lenticulateshapes may also be used. The tip shape when seen from the frontal viewmay vary and may include oval, rectangular, serrated, scalloped,grooved, or geometric. Although one favored embodiment provides a shaftthat has a cross-sectional shape that is flat or planar, acceptablealternative versions of the shaft may be oval, circular, trapezoidal orgeometric on cross-section. Although an embodiment provides a tip havinga shape with alternating protrusions and recessions, acceptablealternative versions of the tip shape may be semicircular, lenticulateor geometric.

For mid and lower face-lifting/tightening the surgeon makes three ormore relatively small incisions only in the skin in front of the earsand under the chin. Forward and lifting force are then applied to theshaft of the device by the surgeon's hand to uniformly separate andmaintain tissue planes while the shape of the device excludes criticalstructures (nerves, vessels) thus avoiding entanglement or trauma orindiscriminate cutting of these important structures. The sameprotrusions (in the most-preferred embodiment) that exclude criticalstructures by virtue of their relationship to the cutting recessedsegments also serve to position the depth of the present invention withrespect to the lower dermis. The spacing of the relative protrusions(bulbs) and relative recessions (lysing segments) maintains the trackingof the instrument. The beneficial feeling of “tracking” is instantlypalpable by the surgeon on device motion and requires no monitor to knowhow the device is moving. Both the number and spacing of protrusions inone embodiment will aid in reducing wobble or lateral (horizontal)slippage during forward thrusting of the shaft. Vertical slippage isprohibited as well in one embodiment; the width of the protrusions/bulbsmaintains the correct distance between the lysing/recessed segments anda portion of the delicate underside of the superficial skin or dermiscontaining the vital blood supply from the dermal plexus of vessels.Very beneficially, the tip of the device and the action of the devicecan be felt/appreciated without direct visualization (endoscope). Thesurgeon can palpably feel whether the device is tracking in the properlocation; the feel of the device as it moves with palpable and easilygrade-able resistance through the facial tissues can immediately tellthe user the location and the amount of undermining that has occurred atthat location. Uniquely, this device creates uniform tissue planes,which can be uniformly energized. No fibrous walled tunnels ornon-uniform irregular fibrous ridges are left following passage thatwould fall prey to irregular energy gradients.

Embodiments using a Protrusions/Recession version, a Laser-Energizedversion, a Monochromatic/Polychromatic Light version, a Thermal version,a Low-Mid Frequency “Regular” Ultrasound-Energized version, aHigh-Frequency Ultrasonic-Energized version, a Reciprocating Energyversion, and Electrosurgical/Radiofrequency-Energized version, aThermal/Heating-Iron-Energized version, and a Microwave-Energizedversion have been described in this application, those co-pending andissued.

Prolotherapy (nontraditional) may be used in conjunction with theinstant surgical device. The use of the instant surgical device providesa unique for prolotherapy to affect precisely separated facial tissueplanes. The use of prolotherapy (traditional or nontraditional) has not,to our knowledge, ever been described in conjunction with an internalapproach to skin rejuvenation. If one considers prolotherapy to be theinjection to irritating compounds into the body to stimulate a vigorouscollagenous response then the above conclusion is true. It may be arguedthat external approaches to stimulating fibroblast/collagen reformationof the surface skin such as deep chemical peeling (with chloroaceticacids or phenol), however their effects cannot reach the deepest aspectsof the skin without gross and permanent deformity of the surface skin:the delicate epidermis.

The following is a brief background on the uncommon topic ofprolotherapy taken from the available medical literature. Prolotherapyis also known as nonsurgical ligament reconstruction, sclerotherapy,sclerosant therapy and regenerative injection therapy. In the 1950s, Dr.George Hackett, a general surgeon, theorized that chronicmusculoskeletal pain often resulted from lax ligaments and tendons(Hackett G S. Ligament and Tendon Relaxation-Treatment by Prolotherapy.3^(rd) ed. Springfield, Ill.: Charles C. Thomas Publishers; 1958:1-151).Hackett injected glucose solutions into tissues to induce a fibroblasticresponse resulting in scar tissue formation and ligament and tendonstrengthening. Hackett termed this treatment prolotherapy, derived fromthe Latin word meaning to proliferate. Since its original description,prolotherapy has been used for treatment of a variety of musculoskeletalconditions, including osteoarthritis, back pain, neck pain,fibromyalgia, and whiplash headache among others. A variety ofsclerosing or proliferative solutions have been used in prolotherapyinjections including hypertonic glucose (D-glucose), sodium morrhuate,and phenol. Injections are ideally placed near the affected tendon orligament-to-bone junction with avoidance of direct ligament injection asthis has the potential to cause ligament destruction and rupture. Themost common adverse effect is pain at the injection site (Kim S R,Stitik T P et al. Critical review of prolotherapy for osteoarthritis,low back pain, and other musculoskeletal conditions: A psychiatricperspective. Am J Phys Med Rehabil 2004; 83:379-389). Case reports andcase series have reported improvement in patients with chronic headacheand neck pain treated with prolotherapy but have lacked adequate controlgroups for comparison (Abraham I. Prolotherapy for chronic headache.Headache 1997; 37:256). Randomized and quasi-randomized controlledtrials have examined the efficacy of prolotherapy in the treatment ofchronic back pain, in many cases in patients in which standard therapieshave failed (Kim S R, Stitik T P et al. Critical review of prolotherapyfor osteoarthritis, low back pain, and other musculoskeletal conditions:A psychiatric perspective. Am J Phys Med Rehabil 2004; 83:379-389.Yelland M, Glasziou P et al. Prolotherapy injections, saline injections,and exercised for chronic low-back pain: a randomized trial. Spine 2003;29:9-16. Yelland M, Mar C et al. Prolotherapy injections for chroniclow-back pain. Cochrane Database Syst Rev 2004; 2:CD004059). Althoughstudies have shown some benefit of prolotherapy for back pain, datacannot be pooled for meta-analysis due to clinical heterogeneity amongstudies; study results are confounded by a lack of adequate controls andthe presence of co-interventions (Kim S R, Stitik T P et al. Criticalreview of prolotherapy for osteoarthritis, low back pain, and othermusculoskeletal conditions: A psychiatric perspective. Am J Phys MedRehabil 2004; 83:379-389. Yelland M, Mar C et al. Prolotherapyinjections for chronic low-back pain. Cochrane Database Syst Rev 2004;2:CD004059). Prolotherapy has shown some promise in the management ofosteoarthritis of the thumb and fingers with 10% dextrose injections,although study sizes have been small (Reeves K D, Hassanein K:Randomized, prospective, placebo-controlled double-blind study ofdestrose prolotherapy for osteoarthritic thumb and finger (DIP, PIP, andtrapeziometacarpal) joints: Evidence of clinical efficacy. J AlternComplement Med 2000; 6:311-20).

A commonly used list of prolotherapy sclerosing or proliferativesolutions includes glucose, sodium morrhuate, and phenol. The effects ofsuch chemicals on human tissue may be thought of as controllable traumato induce a fibroblast/collagen response. However, it stands to reasonthat other solutions that are relatively nontoxic to animal tissue inlower concentrations but caustic, irritating or toxic in somedose-dependent or higher concentrations can also serve well inprolotherapy and may include, but should not be limited to, other sugarsolutions, polidocanol, salts (ie, NaCl), sodium docecyl sulfate. Suchsolutions can be injected into the pockets lying between the surgicalplanes created by the minimally invasive surgical device. Chemicallyinduced tissue irritation or trauma will develop in the areas thusinitiating a local fibroblastic response with collagen and tissue groundsubstance production, fibroblast proliferation and resultant tissuetightening and rejuvenation. The aforementioned agents are solutions,however the use of non-solutions including micelles, foams andsuspensions or even mixtures of insoluble materials could bring aboutsimilar fibroblast/collagen tissue responses. Non-solutions that canirritate or controllably traumatize human tissues into afibroblast/collagen response could include, but should not be limitedto, silicone/saline suspensions, collagen suspensions, fat globule/oilwater suspension, sand, glass, plastic granules, other insolublegranules, soaps, ground microbiological, plant or animal matter. Thesetype of materials would cause a microgranulomatous response withcollagen/fibroblast proliferation. Of course all of the above materialswould be injected sterile into the pocket and any excesses evacuated ordrained at the appropriate treatment time period.

For decades plastic surgeons have inserted biological andnon-biological, organic and inorganic meshes into the face to remedydefects and lend support, and other areas such as the abdomen and grointo lend support and to hold back herniated tissues. However, placementof the meshes necessitated much larger surgical openings than would benecessary with applicant and co-pending which are uniquely able to allowlarge potential free surface areas for mesh to be implanted upon whilefitting such large meshes through only minimally invasive incisions.

The present invention can be used to improve the efficacy and safety offace-lifting and face-tightening and is thus useful in a variety ofcosmetic procedures. The forgoing and other objects, features, andadvantages of the present invention will become apparent from thefollowing description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows pertinent layers and critical structures of the skinincluding the epidermis, dermis, hair follicles, subdermal plexus ofblood vessels, subcutaneous (fatty layer) and the fibrous attachments.Also shown is location of invention's action in relation to theselayers.

FIG. 1B is adapted from the classic textbook of plastic surgeons Bakerand Gordon, Surgical Rejuvenation Of The Face showing the pattern ofpassage of a cylindrical object (differing from applicant) in thesubdermal fibrofatty layer of the face that will result in theirregular, ridge-like, tunnels and walls.

FIG. 1C is adapted from the classic textbook of plastic surgeons Bakerand Gordon, Surgical Rejuvenation Of The Face showing the irregular,ridge-like, dense fibrous attachments associated with tunnels and wallsthat result from passage of a cylindrical object (differing fromapplicant) in the subdermal fibrofatty layer of the face.

FIG. 1D shows a side view divided into quarters of same layers of theskin. Each quarter shows a view of the location and result of passage ofdiffering classifications of energized probes and tip configurations.Applicant is displayed on opposite quarters for contrast.

FIG. 2 shows a lateral or side view of typical incisions and points ofinsertion for the facial tightening and strengthening device,manipulation of the device, and superficial nerve path locations.

FIG. 3 shows a side view of points of insertion and vectors of tissuepassage.

FIG. 4 shows a frontal view looking upward of typical incisions andpoints of insertion for the facial tightening and strengthening device,and superficial nerve path locations.

FIG. 5A is a top view of the apparatus with a focus on the distal shaftand tip region.

FIG. 5B is a top view of the tip area of the apparatus with a focus onthe areas of relative protrusion and relative recession.

FIG. 5C is a frontal view of the tip area of the apparatus with a focuson relative protrusions, relative recessions and associated energizedsegments.

FIG. 5D Front view of tip showing various relative protrusions includesa wide variety of geometric shapes such as stacked rectangles or taperedthin rectangles.

FIG. 5E is a top view of the tip area of the apparatus with a focus onthe relative recession. Also shown are various possible locations withrespect to it for the electrosurgical lysing element (left to right):recessed inside the relative recession or flush with the relativerecession or protruding out from the relative recession.

FIG. 5F is a front view of the tip showing the substantially planaralignment of the relative protrusions and relative recessions. A rangeof potential embodiments take place within a rectangular field (left toright): completely planar, “Barber-shop” tip, curviform, geometric. Alsoshown are a variety of physical contact relationships between therelative recessions and relative protrusions including (left to right):bottom junctions, below junctions, angulate junctions.

FIG. 6A is a top view of electrosurgical embodiment of tip, shaft,handle and relative location of the planar-tissue-altering-window/zone.

FIG. 6B is an enlarged plan or top view of an electrosurgical embodimentwith a focus upon the components and major leads to theplanar-tissue-altering-window/zone. Also shown are various geometriesfor electroconductive tissue denaturing termini (left to right): cone,pyramid, round, geometric, bristle, bristle on spring, bristle with“frizzies”.

FIG. 7 is a top view of LASER embodiment of tip, shaft, handle andrelative location of the planar-tissue-altering-window/zone.

FIG. 8 is a top view of tip, shaft, handle and relative location of theplanar-tissue-altering-window/zone for transferring other forms ofenergy, and matter onto target tissue.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is a device that can be used by surgeons toprovide quick and accurate face-lifting maneuvers minimizing the tissuetrauma and removal. The device is comprised of an undermining shaft thatcan be easily positioned between dissection planes in tissue and movedforward to separate tissue planes by lysing all the connecting fibroustissue without the formation of tunnels or fibrous walls. Embodiments ofthe invention provide for a substantially planar application oftissue-altering energy and/or chemicals to the newly created tissuesurfaces. Other embodiments provide a shaft that has a rigidity that issufficient to allow a user to control the distal tip by manipulating theproximal end. A force on the proximal end will produce a correspondingforce on the distal end. The shaft would not be suitable for anintravascular catheter because it would lack the needed flexibility totraverse the vasculature. Sensors monitor tissue values such astemperature, inductance with feedback and control electronics controltissue altering energy or flow for optimal tissue contraction.

FIG. 1A shows a side view of various layers of the skin including theepidermis 10, dermis 20, hair follicles 30, subdermal plexus of bloodvessels 40, subcutaneous (fatty layer) 50 and the fibrous attachments 60extending from the dermis through the subcutaneous to the deeper facialstructures 70. The subcutaneous layer of the face may best be thought ofas the fibro-fatty layer indicating its tough fibrous nature.Preservation of the subdermal plexus of vessels has allowed surgeons tolift faces for most of the last century by hiding face-lift incisionsaround the ear even while cutting the blood supply of the surface skinall the way back to the lips, nose and neck. This is possible because,unlike most areas of the body (where the blood vessels supply thesurface skin from directions perpendicular to the surface), the majorityof the blood supply to the face upper neck is tangentially carried bythe blood vessels of the subdermal plexus. By uniformly sparing thesubdermal plexus blood from the lips, nose and neck surgeons canmaintain the blood supply for complete tissue life in the upper facialflap even following the irregular trauma of the traditional extensiveprocedure. Collagen plays a critical role in the structure and supportof the entire body especially the face; this basic structural protein ispresent in up to 5% of the epidermis, 50% of the dermis and about 20% ofthe subcutaneous layer depending upon the race, location, age andprevious history of trauma in the patient. In the face, the subcutaneouscollagen percentage can be significantly higher if the fatty contentdecreases due to many factors. Much of the subcutaneous collagen ispresent in the dense fibrous-septae of the fat. Also shown progressingfrom the right toward the left are the relative protrusions 80 of thespecial tip 90. Hidden from view are the relative recessions containingthe tissue the lysing segments (unseen in this view) as they track tocreate a superior, mostly dermal, uniform tissue plane 95 separated fromthe mostly fibro-fatty inferior tissue plane 98. Note Applicant's devicegeometry spares the delicate subdermal plexus by positioning lysingsegments during passage. The unique geometry of the tip upon the propermotion of the device through human or animal flesh gives the surgeonstraight tracking feeling with a characteristic rasping sound andsensation which facilitates easy learning and beneficially allowsvirtual blind operation of the device using solely feeling. The lysingtip 80 passes through the level of the lower portions of the hair bulbs30 thus destroying the hair bulb and causing a high percentage of hairremoval. Hair removal or reduction is a potential benefit in the beardregion of men especially those suffering from folliculitis of the beardregion.

FIG. 1B is adapted from the classic textbook of plastic surgeons Bakerand Gordon, Surgical Rejuvenation Of The Face (Baker, Thomas and Gordon,Howard; C.V. Mosby Co., St. Louis, Mo., 1986) showing the pattern ofpassage of a cylindrical object 90 (differing from applicant) in thesubdermal fibrofatty layer 50 of the face. Note the open flap 95 pulledby a surgical rake consisting mostly of dermis with some dermal plexusattached. This same pattern of passage of the cylindrical object willgenerate the irregular, ridge-like, fibrous tunnels and walls seen inFIG. 1C.

FIG. 1C is adapted from the classic textbook of plastic surgeons Bakerand Gordon, Surgical Rejuvenation Of The Face showing the irregular,ridge-like, dense fibrous attachments associated with tunnels 120 andwalls 110 that result from passage of a cylindrical object (differingfrom applicant) in the subdermal fibrofatty layer of the face. Note thatthe undersurface of the dermal, or top leather layer of the skin flap95, now held by a forceps, will have the irregularly thickened ridgelike pattern attached to its undersurface. The irregular ridges on bothsides of the lysed plane in three-dimensions look similar to thestalactites and stalagmites of a cave. The irregular ridge like patternon the underside of the dermis would irregularly absorb energy appliedto the undersurface. Non-uniform energy absorption yields non-uniformresults; non-uniform results in the face are deformity. Also shown isthe extent of the incision length used in the most common method for atraditional face lift, being over 30 cm in length, to expose a good viewof the fibrous tunnels and walls. The surgeon can then scissor orscalpel cut the walls and connect the tunnels using the naked eye,however, scissors and scalpel cannot fit nor be safely done through theminimally invasive incision sites that applicant uses. Again, onlyapplicant geometry can fit through the minimal 1 cm incision withoutexpanding the incisions and do the separation in under 20 minutes thatcurrently experienced plastic surgeons need the large exposed flap toallow proper visualization and larger instrument cutting.

FIG. 1D shows a side view of same layers of the skin including theepidermis 10, dermis 20, hair follicles 30, subdermal plexus of bloodvessels 40, subcutaneous (fat) 50, and the fibrous attachments 60extending from the dermis through the subcutaneous to the deeper facialstructures. The far left half quarter of this figure displays a typicalcylindrical tip 100, as viewed from the front, representing tipgeometries other than the Applicant. However, virtually all other tipshapes including spatula, single protrusion, recessions from a single ornon-uniform tip, beveled, semicircular, spoon-like, chisel, flat sufferfrom problems similar to cylindrical tips: unwanted tunnel formationwith irregular, thick, remnant denser fibrous walls. The mid leftquarter of this figure shows the instantaneous results of passage of arepresentative cylindrical tip (non-Applicant geometry), as viewed fromthe front. Note the “Swiss cheese” like hole-effect 120 with denserfibrous-septal-walls 110 & 130 separating the holes as a result of thepassage. Unlike a mountain road tunnel forming device that slowlydrills, grinds, removes and spits back all the hard rock before movingforward, none of the art to date is powerful enough, even theliposuction versions (after numerous passages) to completely remove allthe soft fat in its path, let alone remove fibrous-septal-walls. Even ifsuch devices were this aggressive, excessive removal of facial fatleaves patients with what surgeons desperately try to avoid and seek tocorrect: a skeletonized hollow look. It is the plump wrinkle-filling fatin the face that greatly contributes to a youthful appearance. The lossor descending of facial fat from normal positions contributes an aginglook to the face. Disadvantageously, very little of the fibrous tissuein the path of the current art can be completely removed or vaporized,especially the dense collagenous fibrous septal walls which are known tomake up a good portion of the human facial fatty underlayer. The alreadydense septal collagen is thus compacted into even more dense,potentially energy absorbing, collagenous fibrous-septal-walls -110-following non-applicant-tip-geometry instrument passage. The compactionand displacement of the collagenous septae following axial passagethrough minimal incision sites using non-applicant-tip-geometry resultsin highly irregular denser fibrofatty walls especially forming ridges120 attached to the dermal underside. Furthermore, immediately followingpassage of non-Applicant-tip-geometry, the tunnels collapse into tissueslots 130 that may be oriented in many irregular directions as shown inthe left half of the figure. In the middle right part of FIG. 1 b,progressing from the right toward the left, is the relative position ofthe of applicant's dermal plexus protecting lysing tip 140 and attachedshaft 150 having come from the far right after uniformly separating thetissue planes without leaving irregular fibrous walls or ridges. On thedistal superior end of the shaft is theplanar-tissue-altering-window/zone 160 which may accommodate variousforms of energetic devises or tissue-altering chemical dispersing portsas described in applicant's and co-pending art. Note the uniformity ofthe tissue planes that are formed on the right side of the diagram andthe absence of irregular dense fibrous septal compactions. Irregulardense fibrous septal compactions would irregularly absorb appliedtissue-modifying energy and irregularly expose the target tissue tochemical gradients.

FIG. 2 shows location and orientation of minimally invasive facialincisions, which are the points of instrument insertion 210 through theepidermis and dermis for the facial tightening and strengthening device.Also shown are double dashed circles 215 around superficial nerve pathswhich all present day plastic surgeons currently avoid duringface-lifting and which are also recommended not to be undermined withany energized device including applicant's. Even the use of smoothnonenergized liposuction cannulas in these zones has been well reportedin the medical literature to cause temporary or permanent damage to thedelicate motor nerves of these areas resulting in palsy. The partial topview of the face-lift apparatus of the present invention shows how thehandle 220 of the apparatus is be gripped in the hand 225 of the user ofthe device. The shaft 230 with the special lysing tip 235 of theface-lift apparatus is inserted through standard openings in the skin210 or at other suitable locations on the face of a patient. Singledashed lines indicate the portion of the device hidden from view underthe skin. Curved stretch lines 260 indicate the upward force applied onthe device and shaft 230 slightly tenting the overlying skin of theface. The apparatus is firmly pushed forwardly while being liftedforcefully by the operator to perform its function and maintain theplane of undermining. On the distal superior end of the shaft is theplanar-tissue-altering-window/zone 240 (dashed and hidden from clearview in this representation) from which various forms of energy andtissue-altering-chemicals are allowed egress. Tissue altering energy andor chemicals traverse a portion of the length of the apparatus toplanar-tissue-altering-window/zone via energy delivery and matterdelivery means contained in conduit 350 and external line. An accessoryconduit may travel along the underside of the device opposite thetenting skin side to maintain a streamlined shape if greater space isnecessary than available in the shaft. The handle may contain anoptional ultrasonic transducer piezoelectric and thus may impartultrasonic energy to the shaft and tip facilitating passage of theinstrument through fibro-fatty tissue.

FIG. 3 shows a side view of location and orientation of minimallyinvasive facial incisions 210 as well as arrows showing the vectors 300of planar passage for the facial tightening and strengthening device310. Contraction along the direction of the vectored lines is beneficialsince these are the customary tension lines that plastic surgeons stitchin parallel to re-create youth during a traditional face-lift. Bymeticulously using scissors and scalpel, plastic surgeons strive toavoid injuring the subdermal plexus blood supply during tissue planeseparation so as to allow blood from the lips, nose and neck to flowthrough to the tissues supplied by remaining plexus vessels of the ofthe traditional face-lift flap. Since Applicant's device is meant topass from only several incision sites, as opposed to cutting around theentire ear and temple, an even greater blood supply is available fromthe subdermal plexus to nourish the healing skin following applicant'smethod. Reductions in energy delivery are at greater distances (areas320 demarcated by double dashed lines) of facial plane lysis from theremaining available blood supply attachment. These reductions minimizedistant plexus and surrounding tissue trauma and therefore lessen thehealing tissue nourishment burden.

FIG. 4 shows a frontal view looking upward at typical incisions andpoints of insertion 210 as well as arrows showing the vectors 300 ofplanar passage for the facial tightening and strengthening device 400.Note again, the same double dashed circles 410 around the samesuperficial nerve paths to be avoided as seen from this view.

FIG. 5A is a top view of the face-lift apparatus. The tip 80 may beslightly larger than the shaft 90. Handle 220, coagulation and cutfinger control buttons 510 leads to tip and 520 lead totissue-altering-window/zone. However, the tip is preferably 1 cm inwidth and 1-2 mm in thickness for standard facial work and may besomewhat larger or smaller than the shaft. Sizes one-fifth to five timesthese dimensions may also have a need and find a use. For specializedwork such as the eyelids, a proportionately smaller device, shaft andtip may be used of 2-4 mm in width. The tip can be a separate piece thatis secured to shaft by a variety of methods such as a snap mechanism,mating grooves, plastic sonic welding, etc. Alternatively in this model,tip can be integral or a continuation of shaft made of similar metal ormaterials. The tip may also be constructed of materials that are bothelectrically non-conductive and of low thermal conductivity; suchmaterials might be porcelain, ceramics, glass-ceramics, plastics,varieties of Teflon®, carbon, graphite, and graphite-fiberglasscomposites. Additionally, the tip may be constructed of a support matrixof suitable insulating material (e.g., ceramic or glass material such asalumina, zirconia: Kyocera Industrial Ceramics Corporation, Elkgrove,Ill.). Sealing material for a ceramic embodiment should have acompatible thermal expansion coefficient and a melting point differingfrom that of platinum or titanium and alumina or zirconia, typicallybeing a glass or ceramic. A favored ceramic for tip construction isForsterite of 2.9 g/cm³ density, flexural strength of 1500/kg/sqcm,temperature expansion coefficient (83+/−5)10E-7, composition: Al₂O₃0.8%, SiO₂ 41.7%, MgO 51.5%, BaO 6%. Another favored ceramic for tipconstruction is BK 94-1 (Russian Index), flexural strength of3200/kg/sqcm, composition: Al₂O₃ 94.4%, SiO₂ 2.8%, MnO₂ 2.3%, Cr₂O₃0.5%. An external power control bundle -535- connects to electricallyconductive element or wiring -530- brings RF electrosurgical energy froman electrosurgical generator down the shaft to electrically conductivelysing elements mounted in the recessions. The tip may alternatively bemade partially or completely of concentrically laminated or annealed-inwafer layers of materials that may include plastics, silicon, glass,glass/ceramics or ceramics. Alternatively, the tip may also beconstructed of insulation covered metals or electroconductive materials.The shaft is usually flat, rectangular or geometric in cross-section orcan be a somewhat flattened. Smoothing of the edges of the shaft reducesfriction on the skin surrounding the entrance wound since it is the apexof repetitive spokewheel passages. The shaft may be made of metal orplastic or other material with a completely occupied or hollow interiorthat can contain insulated wires, electrical conductors, fluid/gaspumping or suctioning conduits, fiber-optics, or insulation. Shaftplastics, such as Teflon® may act as insulation about wire orelectrically conductive elements. Shafts of any metal or alloy mustcontain sufficient insulating materials within to prevent unwanteddischarge or conduction between internal elements and the shaft or tip.The shaft may alternatively be made partially or completely ofconcentrically laminated or annealed-in wafer layers of materials thatmay include plastics, silicon, glass, glass/ceramics, ceramics carbon,graphite, graphite-fiberglass composites. Depending upon the embodiment,an optional electrically conductive element internal to shaft conductselectrical impulses or RF signals from an external power/control unit(such as a Valleylab electrosurgical generator, Valleylab, a divisionUnited States Surgical of Norwalk, Conn., a further division of TycoHealthcare) to the planar-tissue-altering-window/zone 540. Note that theplanar-tissue-altering-window/zone is meant only to be relatively planarand may even take on a shape that represents a portion of the shape of ashaft, therefore somewhat arced or stairstep or other geometricmodifications of the window/zone are possible. The conduit also containsthe necessary electrical control wires necessary for device operation.Hidden from this direct view in this diagram, and located at the mostproximal portion of the groove of a relative recession is electricallyconductive tissue lysing element, powered by electrosurgical generator,which effects lysing of tissue planes on forward motion of the deviceand is located at the terminus of conductive element. Optional locationsfor multiple impedance sensors or multiple thermal sensors 550 which areused to monitor the local post passage electrical impedance and thermalcondition exist near the distal tip of the shaft. Temperature andimpedance values may be tracked on a display screen or directly linkedto a microprocessor capable of signaling control electronics to alterthe energy delivered to the tip when preset values are approached orexceeded. Typical instrumentation paths are widely known such as thermalsensing thermistors feed to analog amplifiers which in turn feed analogdigital converters leading to a microprocessor. Internal or externalultrasound measurements may also provide information which may beincorporated into a feedback circuit. An optional mid and low frequencyultrasound transducer can also be activated to transmit energy to thetip and provide additional heating and improve lysing. A flashingvisible light source, for example an LED can be mounted on the tip toshow through the upper skin flap to identify the location of the device.

FIG. 5B is a top view of the tip area of the face-lift apparatus. Thetip 80 is made of materials that are both electrically non-conductiveand of low thermal conductivity such as porcelain, epoxies, ceramics,glass-ceramics, plastics, or varieties of Teflon®. Alternatively, thetip may be made from metals or electroconductive materials that arecompletely or partially insulated. Note the relative protrusions 560 andrelative recessions 570 visible from this viewing angle. For thepurposes of this and related applications we shall define or qualify adevice as having protrusions and recessions at the tip if, when viewedthree-dimensionally from at least one angle, then at least two relativeprotrusions and at least one relative recession can be seen. In order toprotect the subdermal plexus of blood vessels, the protrusions areusually nonconductive electrically and minimally conductive thermally.Various materials may insert into, pass along, associate with, projectfrom, or further recess into the concavity of the relative recessions;these materials are usually electrically conductive which we will nameelectrically conductive lysing elements. The tip shown in thisembodiment has four relative protrusions and three relative recessions.Electrically conductive lysing elements 565 are seated into the relativerecessions. This particular embodiment in FIG. 5B provides for amonopolar tip conductive element. Note the relatively oval-protrusionsare shaped similarly to a commercial jetliner nose cone in order toreduce drag and lower resistance to facilitate tissue passage. However,the tip protrusion shapes may take on a wide variety of geometric shapesincluding but not limited to stacked rectangles or tapered thinrectangles (FIG. 5D 560). Other relative projection shapes may includebut should not be limited to spheroid, sphere, sphere on cylinder,sphere on pyramid, sphere on cone, cone, cylinder, pyramid, andpolyhedron. Whatever variety of tip shape is chosen, the customaryoverall composite tip width can vary between 2 mm and 20 mm, mostpreferably between 8 mm and 12 mm while the thickness may vary between0.5 mm and 4 mm, most preferably 1-2 mm. Adjacent the tip, but possiblyincorporated into the tip, is the planar-tissue-altering-window/zone540. In the relative recessions of the tip is the electricallyconductive tissue lysing element 565 (usually hidden from view at mostangles) which may have any geometric shape including a thin cylindricalwire. The electrically conductive lysing element can be in the shape ofa plate or plane or wire and made of any metal or alloy that does notmelt under operating conditions or give off toxic residua; optimalmaterials may include but are not limited to steel, nickel, alloys,palladium, gold, tungsten, copper, and platinum. These metals can becomeoxidized thus impeding electrical flow and function. Calculatedoxidation of the electrically conductive lysing elements may be used toplan obsolescence so that one embodiment of the device may be a lowcost, disposable, one-time-use device. However, other embodimentsintended for multiple use require the tip's electrically conductivetissue lysing elements be protected or coated with materials thatinclude but are not limited to Silverglide™ non-stick surgical coating,platinum, palladium, gold and rhodium. Varying the amount of protectivecoating allows for embodiments of varying potential for obsolescencecapable of either prolonging or shortening instrument life. Theelectrically conductive lysing element portion of the tip may arise froma plane or plate of varying shapes derived from the aforementionedmaterials by methods known in the manufacturing art, including but notlimited to cutting, stamping, pouring, molding, filing and sanding. Thiselectrically conductive lysing element plate 565 may be an insertattached to a conductive element in the shaft or continuous with aformed conductive element coursing all or part of the shaft. Anelectrically conductive element or wiring 580 brings RF electrosurgicalenergy down the shaft to electrically conductive lysing elementsassociated in part with the recessions. The electrically conductiveelement or wiring may be bifurcated to employ hand switching if anoptional finger switch is located on handle; the electrically conductiveelement or wiring leading from the shaft into the handle may be bundledwith other leads or energy delivering cables, wiring and the like andexit the proximal handle as insulated general wiring to variousgenerators (including electrosurgical), central processing units, lasersand other sources as have been described herein. The plate may besharpened or scalloped or made to slightly extend outwardly from the tiprecessions into which the plate will fit. Alternatively, since cuttingor electrical current can cause an effect at a distance without contactthe electrically conductive lysing element may be recessed into therelative recession or flush with it. Adjustable, locations of theelectrically conductive lysing element with respect to the relativerecession may be achieved by diminutive screws or ratchets. The plate,which is most desirably between 0.01 mm and 1 mm thick, can be sharpenedto varying degrees on its forward facing surface. Plate sharpness mayincrease the efficiency with which electricity will pass from the edgecutting the target tissue. However, proper function even when variablydull or unsharpened may be unhampered since electrosurgical cuttingcurrent immaterially cuts beyond the electroconductive edge by adistance of usually between 0 and 1 mm. Plate sharpness may be adisadvantage in determining whether a tip lysing conductor portion istoo oxidized to function efficiently because scalpel like cutting mayallow passage of the instrument but likely may also lead to increasedbleeding when electrical cutting current is absent. Because standardoperating forward motion of the invention's tip exposes it to relativelycooler tissue fluid temperatures, the heat of operation at the tip theelectrosurgical tissue lysing conductor should not reach temperaturesthat will unseat it for significant operating times, however underrelatively “dry” conditions or protracted usage periods, secondary andtertiary methods of insulation at the junctions between the tip properand the electrosurgical tissue lysing conductor may be needed to preventmelting at the tip and unseating. For example, thin ceramic coatings ofunder one-one hundredth of an inch thick may be epoxy bonded to thesurface of the electrosurgical lysing conductor plate in all but thepoints of tissue exposure, the ceramic coating may further be coatedwith (but not all-inclusively) olefins, Halar®(monochlorotrifluoroethylene that may soften near 550° C.), Teflon®(tetrafluoroethylene that may soften near 750° C.), FEP (fluoronatedethylene polypropylene, HMWPE (high molecular weigh polyethylene) orepoxy by methods Vitek Corp., Derby, Conn. Plates singly or doublyinsulated in this manner may then be seated into an appropriatelymatched recipient tip structure with less risk of melting followingprolonged operating discharge. The electrically conductive lysingelement may also exist in the shape of a simple wire of 0.01 mm to 3 mm,preferably between 0.1 mm and 1 mm, and be uncoated or coated with theaforementioned similar materials to prevent oxidation or modifyobsolescence. The wire may be singly or doubly insulated as wasdescribed for the plate and may have the same electrical continuities aswas discussed for the planar (plate) version. The preferredelectrosurgical current for the electrically conductive lysing elementis of the monopolar “cutting” variety and setting and may be deliveredto the tip lysing conductor in preferably a continuous fashion butoptionally a pulsed fashion as well. The surgeon can control thepresence of current by a foot pedal control of the electrosurgicalgenerator or by button control on the shaft (forward facing button). Theamount of cutting current can be modified by standard interfaces ordials on the electrosurgical generator. The tip current can be furtherpulsed at varying rates by interpolating gating circuitry at some pointexternal to the electrosurgical generator by standard mechanisms knownin the art preferably at rates of 1 per second to 60 per second. Formost of the combination embodiments, for the electrically conductivelysing element is a monopolar tip in contact with conductive elements inthe shaft leading to external surgical cable leading to anelectrosurgical generator from which emanates a grounding or dispersiveplate which is to be placed elsewhere in contact with the patient'sskin, preferably the thigh. Such circuitry is controlled and gated/wiredfrom the cutting current delivery system of the electrosurgicalgenerator. Acceptable Valleylab electrosurgical generators includeValleyLab Force 1B with maximum P-P voltage of 2400 on “cut” with arated load of 300 Ohms and a maximum power of 200 Watts, maximum P-Pvoltage of 5000 on “coagulate” with a rated load of 300 Ohms and amaximum power of 75 Watts; ValleyLab Force 4 has a maximum P-P voltageof 2500 on “cut” with a rated load of 300 Ohms and a maximum power of300 Watts, 750 kHz sinusoidal waveform output, maximum P-P voltage of9000 on “coagulate” with a rated load of 300 Ohms and a maximum power of120 Watts using a 750 kHz damped sinusoidal with a repetition frequencyof 31 kHz. The tip may also be manufactured from multilayer wafersubstrates comprised of bonded conductive strips and ceramics;conductive materials include those already described for tipmanufacture. Some tip embodiments, when viewed only from the top displayrecessions flush with protrusions, however at some other viewing anglethe difference become apparent. In an alternative embodiment, theelectrically conductive lysing elements may be bifurcated or dividedinto even numbers at the relative recessions, insulated and energized bywiring to an even number of leads in a bipolar fashion and connected tothe bipolar outlets of the aforementioned electrosurgical generators.Rings partly or completely encircling the shaft of the hand unit can belinked to a partner bipolar electrode at the tip or on thetissue-altering-window/zone. Such bipolar versions will decrease theavailable power to electrically modify certain tissues, especially thethickest.

FIG. 5C is a front view of the tip of the face-lift apparatus. The tiphas four protrusions 560 now seen as ovals and three recessions 570 nowseen as thinned lines, which contain seated electrically conductiveelements 565. Note the relatively oval shaped-protrusions in seen fromthis angle. Regarding the nomenclature used to describe bulbs and lysis,relative protrusions and relative recessions, protected and exposed, inthis and copending applications: relative protrusions are usuallyexposed and probe-like and bulbous; relative recessions are protectedareas and capable of lysing tissue. We would classify any design thatshows a relative protrusion or relative recession from at least oneangle of viewing to represent a protrusion or recession and fit thedescription of this device. Tip protrusion shapes can include a widevariety of geometric shapes especially those that facilitate smoothinstrument passage and maintain adequate spacing from the firm dermallayer. In an alternative embodiment, the tip or distal shaft is made ofmetal that is electrically insulated at all points, excluding therelative recession(s), and excluding the contact points for leads fromthe energy source; this allows for electrosurgical energy passage at theareas of the energized lysing segments.

FIG. 5D is a front view of tip showing various shapes of relativeprotrusions 560 including but not limited to a wide variety of round orgeometric shapes such as ovals, stacked rectangles or tapered thinrectangles.

Referring now to FIG. 5E, alternatively, since cutting or electricalcurrent can cause an effect at a distance without contact theelectro-conducting tissue lysing element (dashed lines indicatedifficult to view) may be recessed into 571 the relative recession 570or flush 572 with it. The difference between the relative recessions mayvary 0.001 mm to 10 mm in depth with respect to the relative protrusionswhen viewed from the top. Also shown for comparison is anelectroconductive lysing element that is projecting slightly 573 fromthe relative recession.

FIG. 5F shows the alignment of the relative protrusions and relativerecessions is substantially planar and thus may include embodiments thatare completely planar 580 or those with some arc, or curvature 581 oreven geometric 583 within a substantially planar range indicated by thedashed rectangle 584. Also shown is the “Barber-shop” embodiment 582 ofthe tip in which the rectangles become infinitely thin in a directionperpendicular to a line through the axis of the ends of the protrusions.Additional embodiments include but are not intended to be limited tothose in which the plane of the relative recessions is not locatedwithin the plane passing through the horizontal center of the relativeprotrusions. Instead the relative recession plane may be located below582 or at some other extreme point relative to the horizontal planethrough the relative protrusion. Altered positioning will effect thedepth of lysing and amount of intraoperative and postoperative bleedingas well as dermal plexus damage. In several embodiments, the pluralityof protruding members can define a first plane on one side of the lysingmechanism and further define a second plane on the side of the lysingmechanism that is opposite to that of the first plane; the lysingmechanism is fixed in a location substantially parallel to and withinthe range extending from the first plane and the second plane; theapparatus is configured to cut two opposing and substantially planartissue planes that are parallel with the first plane and the secondplane as the apparatus is pushed through tissue.

FIG. 6A is a top view of an internal schematic of the tip 80, shaft 90,handle 220 of an electrosurgical embodiment of theplanar-tissue-altering-window/zone 160. Wire bundle containingconductive element 610 leading to switch attached to “cut” (cuttingcurrent) control button 510 which then leads to lysing tip insertscomprised of at least electrically conductive lysing elements. Wirebundle also contains other leads that pass through handle and shaft aswell as single, grouped or arrays of optional tip thermal and impedancesensors. An output device interposed along leads connected to sensors islocated somewhere outside the handle and may display the temperature inCentigrade or elicit feedback control through a CPU. Other sensors suchas impedance sensors may follow a similar path and read-out (Ohms) withfeedback inhibition. For the microwave radiofrequency or monopolarradiofrequency electrosurgical window/zone embodiment, also passingthrough wire bundle 620 outside the shaft, is conductive element (whichis bifurcated if it optionally leads to control switch attached to“coag” (coagulate current) control button 520) that eventually leads toenergetic element at planar-tissue-altering-window/zone. Footswitchcontrol or voice activated control for theplanar-tissue-altering-window/zone would be convenient since theoperating surgeon's hand may be occupied with device motion andactivation of the electrosurgical tissue lysing conductor.

FIG. 6B is an enlarged plan or top view of an electrosurgical embodimentof the tip 80 and adjacent planar-tissue-altering-window/zone 160.Scattered about said zone are one or many more electroconductive tissuedenaturing termini 630. Preferably between six and twenty termini arepresent. Said electroconductive tissue denaturing termini may bescattered randomly throughout the planar-tissue-altering-window/zone ormay be arranged in patterns. Said electroconductive tissue denaturingtermini may be formed in various shapes and possess varying degrees ofinsulation on various aspects of their geometry and be present innumbers between 1 and thousands. In one preferred embodiment saidelectroconductive tissue denaturing termini are shaped as pointed cones630 with their bases embedded or counter-sunk in theplanar-tissue-altering-window/zone. Other geometrical embodimentsinclude but are not limited to cube shaped, pyramid shaped,hemispherical, sphere shaped with cylindrical attachment area, andcylinder shaped. Insulation may be placed covering between 0 and 100% ofthe contact surface of the termini. The “ladybug” is a dome shapedtermini embodiment covered with insulation containing numerous <0.1 mmholes. Other tertiary shapes may include but are not limited to straightbristle shaped, bent bristle shaped, bristle shaped atop a cone, bristleshaped distally atop spring shape proximally -640-, and bristle shapeswith further branched bifurcation or “frizzies”. The electroconductivetissue denaturing termini may be made any electroconductor or any metalor alloy that does not melt at operating temperatures or give off toxicresidua; optimal materials may include but are not limited to steel,nickel, gold, tungsten, copper, alloys and platinum. Various metals canbecome oxidized thus impeding electrical flow and function. Calculatedoxidation of said termini may be used to plan obsolescence so that oneembodiment of the device may be a low cost, disposable, one-time-usedevice. However, other embodiments intended for multiple uses requiresaid termini to be protected or coated with materials that include butare not limited to Silverglide™ non-stick surgical coating, platinum,palladium, gold and rhodium. Varying the amount of protective coating onthe termini allows for embodiments of varying degrees of obsolescencethat may either prolong and shorten instrument life.Planar-tissue-altering-window/zone and electroconductive tissuedenaturing termini may be formed as multilayer wafer substratescomprised of bonded conductive strips, ceramics, plastics, silicon,glass, glass/ceramics and materials using annealing techniques known inthe art. Carbon, graphite, and graphite-fiberglass composites are alsopotentially useful. Said planar-tissue-altering-window/zone (that seatselectroconductive tissue denaturing termini) may be constructed at leastpartially of materials that are both electrically non-conductive and oflow thermal conductivity; such materials may include but are not limitedto: porcelain, ceramics, glass-ceramics, plastics, varieties of Teflon®and other such materials mentioned herein. Multilayer ceramic electrodesare also commercially available from VisPro Corp. of Beaverton, Oreg.Additionally, said planar-tissue-altering-window/zone may be constructedof a support matrix of suitable insulating material (e.g., ceramic orglass material such as alumina, zirconia: Kyocera Industrial CeramicsCorporation, Elkgrove, Ill.). Sealing material for a ceramic embodimentshould have a compatible thermal expansion coefficient and a meltingpoint different from that of platinum or titanium and alumina orzirconia, typically being a glass or ceramic. A favored ceramic forconstruction is Forsterite of 2.9 g/cm³ density, flexural strength of1500/kg/sqcm, temperature expansion coefficient (83+/−5)10E-7,composition: Al₂O₃ 0.8%, SiO₂ 41.7%, MgO 51.5%, BaO 6%. Another favoredceramic for construction is BK 94-1 (Russian Index), flexural strengthof 3200/kg/sqcm, composition: Al₂O₃ 94.4%, SiO₂ 2.8%, MnO₂ 2.3%, Cr₂O₃0.5%. Depending upon the desired longevity and the potential for theenergy passage from the termini to create temperatures that may be nearthe softening point of such encasements as tetrafluoroethylene,secondary and tertiary methods of insulation of the junction between thetermini and materials that may soften may be needed to preventunseating. For example, thin ceramic coatings of under one-one hundredthof an inch thick may be epoxy bonded to the undersurface of the terminiin all but the points of electrically conductive element or wiringcontact; the ceramic coating may further be coated with materials suchas olefins, Halar®, Teflon®, FEP or epoxies. Termini singly or doublyinsulated in this manner may then be seated into a window/zone comprisedof aforementioned materials. An electrically conductive element orwiring 650 brings RF electrosurgical energy from the shaft andelectrosurgical generator to the electroconductive tissue denaturingtermini mounted in the planar-tissue-altering-window/zone. Heatingderived from the high frequency voltage differential existing betweenelectrodes and the grounding plate results in temporary and permanentcontraction of the surrounding tissues, especially fibrous containingones. Desirable results do not necessitate total cell necrosis, onlypartial denaturing can cause tightening. This embodiment's source ofcurrent from the electrosurgical generator is usually monopolar “Coag”or coagulation mode thus requiring a grounding plate be applied to adistant location on the patient's skin, however desired electrosurgicalgenerator current for other embodiments may lie on the spectrum of a“blend” setting or more than a pure cutting “cut” setting. The surgeoncan control the presence or absence of current by a foot pedal controlof the electrosurgical generator or by button control on the shaft andthe level of cutting current can be controlled by standard interfaces ordials on the electrosurgical generator. The window/zone current can befurther pulsed at higher rates by interpolating gating circuitry at apoint external to the electrosurgical generator by standard mechanismsknown in the art at rates including but not limited to 1 per second to200 per second. Pulsing this embodiment would leave an organized orrandom pattern (spotty) of injury to the target tissues with the optimalchoice being a pulsed rate and energy level that provides for clinicallyunrecognizable minute subsurface areas of damage (fractiles) that induceneighboring tissues to contract in a pleasing fashion. In an alternativeunipolar embodiment, the electroconductive tissue denaturing terminimounted in the planar-tissue-altering-window/zone may be grouped ordivided and wired using techniques standard in electrical engineering tofire in a random pattern, or such a way that the firing of said terminias the instrument is moved provides for a nonuniform or spotty patternof electrosurgical tissue alteration or spotty tissue destruction. In analternative embodiment, the electroconductive tissue denaturing terminimounted in the planar-tissue-altering-window/zone may be grouped anddivided or divided into even numbers, insulated from the oppositeelectronic pair and energized by wiring to an even number of leads in abipolar fashion and connected to the bipolar outlets of theaforementioned electrosurgical generators. Another alternative bipolarembodiment involves placing one or more metal rings around the shaft asthe return or second electrode in a pair with one or more theelectroconductive tissue denaturing termini acting as the first. Suchbipolar versions are weaker and lack sufficient power to electricallymodify the thickest tissues when compared to monopolar versions. Energyavailability may be more problematic when trying to energize or denaturethe subcutaneous fatty layer upon turning the instrument over followingthe initial plane forming passes while trying to precisely “cook thefat” below to get overlying skin contraction. Traumatizing thesubcutaneous tissue or “cooking the fat,” causes inflammation in thesubcutaneous layer which transfers to over-draping dermal flap causingdermal inflammation and thus contraction (unpublished, preparingmanuscript to be submitted to medical journal). Likewise, traumatizingmuscle (in this case the platysma muscle that envelopes most of thefront of the neck) to cause char or other debris, may cause a similarcontractile response in the platysma and the over-draping dermal skinflap. The formation of carbon and carbonized organic chemicals (matter)likely induces inflammation via several pathways including: bringingmacrophages which have to envelope and digest the material and byinducing leakage of cellular mediators which inflammatory cellgatherings and their resultant tissue cascade and tissue modifications.Alternatively, plurality of substantiallyplanar-tissue-altering-window/zones can be present at multiple locationson the shaft, however more proximal locations will not “see” as muchtarget tissue surface area to energize as distal ones because the handlecannot fit into the incision. Furthermore, those multiple possiblelocations on the shaft of substantiallyplanar-tissue-altering-window/zones include placing the window/zone onthe bottom or opposite side of customary use. Zones can be present onboth sides of the shaft, for simultaneous energy or matter transfer.

FIG. 6A also describes a typical operating room equipment set upconnected to the shaft and handle 220 for the monopolar radiofrequencyelectrosurgical planar-tissue-altering-window/zone embodiment. Passingthrough wire bundle, is conductive wire 621 leading to switch 520attached to “coag” (coagulate current) control button further leading toenergetic element at planar-tissue-altering-window/zone. Said circuitoriginates from the “coagulation” controlling and delivering ports ofhigh frequency electrosurgical generators—such as a Valleylab Surgistator Force 1. From separate or similar electrosurgical generators wirebundle contains conductive element 610 leading to switch attached to“cut” (cutting current) control button 510 that further leads toelectrically conductive lysing elements. The patient is grounded to bothmachines using disposable grounding gel plates as dispersive electrodes625. Depending upon the patient's skin type, it may be possible thatusing only the current applied to the plexus protecting tip and itsattached electrosurgical tissue lysing conductor the surgeon canelectro-modify the dermal tissues to the point that cosmeticallyacceptable tightening and strengthening occur. Thus, in some cases (thinskin, age, heredity, etc.) it may not be necessary to use any type ofenergy from the planar-tissue-altering-window/zone if simple energy fromthe cutting tip can cause significant enough tissue contraction, damageand alteration. Although the planar-tissue-altering-window/zone iscustomarily placed on the side of the shaft meant to face superiorly, aseparate planar-tissue-altering-window/zone may be located on theopposite side of the shaft using any form of window/zone emanatingenergy described in this or related applications.

FIG. 7 is an enlarged plan or top view of the macro and microfractilecoherent electromagnetic light (LASER)/noncoherent electromagnetic(light) planar-tissue-altering-window/zone embodiment existing in thesame instrument as previously described tip 80, shaft 90 and handle 220.Passing into shaft and adjacent to or formed into external bundle, aremultiple or single fiberoptic elements 720 leading toplanar-tissue-altering-window/zone 730. The energy passing through thefiberoptic is controlled at the electromagnetic energy source byfootswitch. In one embodiment, the planar-tissue-altering-window/zone isan optical window 730 that allows laser light to exit the shaft andirradiate nearby target tissue. A light delivery means, which can be ahollow waveguide or single or multiple optical fibers (such asmetal-coated plastic manufactured by Polymicro Technologies, Inc ofPhoenix, Az), is contained in external conduit 710. The external conduitcan also be an articulating arm as is commonly used in surgical lasersystems. Additional control wires and power may be delivered to thehandpiece via the external conduit. However, using footpedal controlfrom electromagnetic energy radiation source or control interface, dial,or panel will likely be less cumbersome for the surgeon and reduce theexpense of handpiece finger-control manufacture. Optional window 730,possibly made of Germanium, allows egress of laser light and collectionof data by thermal sensors 550, may be of varying size. In anotherembodiment, a multiplicity of optical fibers may terminate at specificor random places within the planar-tissue-altering-window/zone. Suchbare or coated fiberoptic termini may protrude from, be flush with or berecessed into materials comprising theplanar-tissue-altering-window/zone. Bare fiberoptics that are ethyleneoxide sterilizable may be seated in a thermally nonconductivebackground, preferably at uniform 90 degree angles, but variable anglesbetween 0 and 180 degrees may also be efficacious. The preferred lightdelivery means depends on the wavelength of the laser used. Infraredlight emitted by the heated tissue can also be collected through thewindow and sensed by an infrared detector to measure the tissuetemperature. For CO₂ laser irradiance, reliable sources include standardoperating room units such as the Encore Ultrapulse® from Lumenis Corp.of Santa Clara, Calif. is capable of providing continuous CO₂ laserenergy outputs of 2-22 mJoules at 1-60 Watts, older models of theCoherent Ultrapulse are suitable (Coherent now owned by Lumenis). Thehollow section of shaft may act as a waveguide or may contain ametal-coated plastic fiberoptic or waveguide to allow laser light topass through and exit from window near tip. The window allows egress forlaser light delivered to apparatus. Lasers usable in the presentinvention include both pulsed and continuous wave lasers such as CO₂,erbium YAG, Nd:YAG and Yf:YAG. The beam diameter can be changed instandard manners by those skilled in the art. However, this list is notintended to be self-limiting and other wavelength lasers may be used.The coherent or noncoherent radiation can be delivered from their sourceby articulating arm or fiberoptic (as the case of the wavelength may be)and enter the handpiece and be further directed to theplanar-tissue-altering-window/zone via waveguide and mirror orfiberoptic terminating at a mirror or fiberoptic terminating internallywithin, flush with, or externally from, materials comprising theplanar-tissue-altering-window/zone. One embodiment to produce largermacro-fractile-like areas of target tissue denaturation is to split suchLASER energy as CO₂ into multiple smaller fiberoptics in the range of0.1 mm to 1 mm in diameter CO₂ laser carrying optical fiber manufacturedby Polymicro Technologies, Inc of Phoenix, Az. Said fiberoptics mayterminate axially or at some angle adjacent to a mirror directingradiation to planar-tissue-altering-window/zone so that LASER energyemanates from the window into the target tissue. Said fiberoptics mayterminate protruding from, flush with or recessed in base materialscomprising the planar-tissue-altering-window/zone. Said window/zone maybe homogenous with or materially similar to the rest of the shaft orannealed in to it using methods similar to those described for theelectrosurgical embodiment of the planar-tissue-altering-window/zone.Lower melting temperature plastics may also be suited to seat saidfiberoptics into the planar-tissue-altering-window/zone. Fewer butlarger fiberoptics on the order of 1 mm like those manufactured byPolymicro Technologies may be used to create larger areas of controlledfocal necrosis of the target tissues in the mid and lower dermis.Desirable sizes of tissue destruction of under 1 mm with interposedareas of sparing of the vascular supply help avoid confluences ofaltered tissue and reduce clinically visible scarification seen on closeinspection or at social distances. Assuming forward motion in the targettissue of 1 cm/sec of the planar-tissue-altering-window/zone, LASERpulse frequencies in the range of 1-1000 pulses/second with three ormore fiberoptic termini (preferable arrays include 10 larger diameterfiberoptic termini) would bring about clinically acceptable butsufficiently small local areas of controlled focal necrosis of thetarget tissues. Overly intense nonpulsed continuous electromagneticradiation may streak by tissues in an uninterrupted fashion isolatinglarger areas of tissue from access to fresh oxygenated blood. Lessintense nonpulsed electromagnetic radiation may bring about somecellular contractile response without damage to the blood vessels. Todeliver microfractiles of energy internally the handpiece may be fittedwith a mirror adjacent to the planar-tissue-altering-window/zone suchthat when an adapted laser light source (Reliant MTZ™SR Laser, ReliantTechnologies, Palo Alto, Calif.) is altered in its focal length andfitted to the proximal end of the handle of the embodiment, random orpatterned LASER may be transmitted down the handpiece and shaft onto themirror and redirected out the window in theplanar-tissue-altering-window/zone onto the target tissues. A range ofsettings for internal use may exist, however preferred settings are inexcess of those externally applied by the 1.5 micron unit of 32 J/sqcm.Because of the thickness of the lower dermis and attached subcutaneousgreater energy will be needed when lasing from inside out to produceMicroscopic Necrotic Debris within the dermis leading toward the upperdermis while avoiding damage to the epidermis. Tissue impedance andthermal monitoring devices similar to those described with theelectrosurgical window may be used in conjunction with LASER energywindow/zone devices.

FIG. 8 is a top view of an internal schematic of the handle 220, shaft90, and tip 80 leading to planar-tissue-altering-window/zone 730 capableof delivering various forms of energy to target tissue. Coursing thehandle and shaft are fiberoptics, wiring, conductive elements,evacuation tubing, insulated gas or fluid-transmitting tubing,monitoring leads and any other control and monitoring connections.Optional thermal and impedance sensors may exist in or on the shaft ortip. Planar-tissue-altering-window/zone embodiments for intense pulsedlight emission may be constructed as in co-pending applications and asfollows. In intense pulsed a noncoherent, nonLASER, filtered flashlampemits a broadband of visible light. The flashlamp, such as a smallerversion of that used by ESC/Sharplan, Norwood, Mass. (500-1200 nmemission range; 50 J/sqcm fluence; 4 ms pulse; 550 nm filter) may occupythe handle or window/zone of the embodiment. Should IPL flashlampaccommodations increase shaft thickness significantly, the 1 cm entranceincisions can be easily transformed into 1.5 cm incisions along theanatomic lines and combined with a perpendicular incision of 1-1.5 cm toform a small A to T flap from which a much larger diameter shaft canenter yet be easy to sew. The flashlamp emits optical and thermalradiation that can directly exit the planar-tissue-altering-window/zoneor be reflected off a reflector to also exit through window. Thereflector can have a parabolic shape to effectively collect allradiation emitted away from the window which can be made of a widevariety of glass that transmits optical, near infrared and infraredlight (e.g., quartz, fused silica and germanium.) Emission spectra canbe filtered to achieve the desired effects. Thermal emissions or visibleradiation absorption may locally heat the dermis to alter collagen;thermal sensors control reduces overheating. In order to eliminateexcessive heating of the shaft and the surrounding facial tissue, theflashlamp and reflector are thermally isolated by low thermalconductivity materials or cold nitrogen gas can be pumped through ahollow in the shaft or handle. The handle can be an alternate locationfor the so that emitted radiation may be reflected by a mirror throughthe window/zone. A planar-tissue-altering-window/zone embodiment forradiofrequency microwave emission may also be constructed as inco-pending applications; in such an embodiment the shaft may be made ofmetal or plastic or ceramic connected to a plastic or polymer or ceramictip section that has an even total number of phased array antennasattached or exposed on a planar or relatively planar or slightlycurviform side. The phased array of antennas is made of metal(preferably stainless steel, aluminum, gold, steel, or platinum). Thephased array is able to function in the range of 1 to 10 gigahertzyielding up to 20 watts of power with a depth of penetration of 1-3 mm.A cryotherapy embodiment of the planar-tissue-altering-window/zone-730-, utilizes plastic or thermal resistant tubes or tubules 740 on theorder of 0.01 cm to 1 cm to transmit cryotherapy agents via the inert orinsulated tubing 810. In the cryotherapy embodiment, a cold inert gas orliquid such as nitrogen (196° C.) is suitable for one embodiment andmaintained in a cryogenic container or reservoir located outside theshaft and gated nearby there. Cryotherapy agents change, alter, damageor modify targeted tissues not in the freezing (preserving phase) but inthe thawing phase in which thermal energy, derived from the surroundinginternal and external human environment heats the now-thawing targettissues causing damage including but not limited to intracellulardisruption of organelles, cellular membrane lysis, crystallization, andmatter precipitation. A side benefit of nitrogen is stability andinhibition of combustion from nearby operating electrosurgical orelectromagnetic devices. The density compares with the coolingcapability of liquid nitrogen and is about one thousand times that ofnitrogen gas. Nitrogen, in its liquid form, is more difficult totransport from the reservoir to the window without significantthicknesses of insulation. Therefore gas, and mixtures of gas and fluidcontaining mostly gas would be easier to control while maintainingconvenient handpiece size. 1 cc of cold nitrogen gas at “window”temperatures varying from −196 to −30° Centigrade passing at anemissions rate of between 1 cc/0.1 sec to 10 seconds may be coordinatedby thermal sensor feedback loop release to more precisely alter targettissues depending upon target tissue temperature and density at time ofcryotherapy. Released gasses or fluids that would vaporize to sufficientvolumes of gas into the relatively closed cavity between the lysedtissue planes may inflate the face necessitating the use of evacuationtubing or conduits to release gas build-up and pressure 750. Footswitchcontrol or voice activated control (in addition to optional thermalsensor/CPU feedback loops) of fluid release would be convenient sincethe operating surgeon's hand may be occupied with device motion oractivation of the lysing function.

Direct piezoelectric versions of the tissue-altering-window/zone mayimpart vibrational energy to water molecules contained in target tissuespassing adjacent to the piezo. Temperature elevations cause collagenouschange and cell wall damage, however ultrasonic energy application mayhave disruptive effects at the subcellular level as well. Crystals thatacquire a charge when compressed, twisted or distorted arepiezoelectric. Electrical oscillations applied to certain ceramic waferscause ultrasonic mechanical vibrations. Energy output for piezoelectricwindow/zones should range from 1-30 J, with a preferred range of 1-6 Jin a surgical device moving about 1 cm/second. As with all otherembodiments, temperature and impedance sensors providing intraoperativereal-time data can modulate energy input into the piezoelectric which isenergized by conductive element in shaft in further connection withcontrol unit and power supply. In yet another embodiment, hot gasses orliquids or combinations thereof may be sprayed from the window/zone ontothe target tissues. For example, collagen denatures at 70° C. andcellular damage builds, steam or hot water can be delivered by a varietyof mechanisms to exit the window/zone onto the target tissues. Steamunder pressure can be delivered via insulated, high-pressurethermal-resistant line from an auxiliary water heating device outside ofthe shaft or handle. The line may divide into one or more tubules beforedelivery to the target tissues; a suction lumen may remove any excesspressure built as a result of gaseous emissions within the relativelyclosed space. Alternatively, steam may be produced by minute individualpiezoelectrics located in the window/zone. In this embodiment, smalltubules deliver a liquid capable of being vaporized within thetemperature range that the small piezoelectrics function, suchpiezoelectrics are currently in use for painting and ink application(MicroFab Tech Inc, Royal Cox, Plano, Tex.). Water is delivered to thepiezoelectric and retrograde motion is prevented by a unidirectionalmicrofluidic flow valve system. Piezoelectrics, numbering between 1 and1,000, may be mounted in an array in the window/zone, with microfluidicsflow valves preventing retrograde motion of water in the waterdepositing flow system. Randomly or nonrandomly, various piezoelectricsmay be controllably made to impart vibrational energy to water moleculesto make localized areas of steam. Steam may be ejected from Teflon® orsimilar tubing in a spotty or uniform fashion to modify or traumatizetissues on either side of the facial dissection plane.

The prolotherapy embodiment of the planar-tissue-altering-window/zoneprovides instillation of hypertonic glucose (D-glucose), sodiummorrhuate, and phenol and other fibrosis-inducing chemicals or mixturesin liquid, foam, suspension, powder, or any other form known to possessthe ability to controllably traumatize tissue or stimulate fibroblastsor increase collagenization (including but not limited to concentratedsalt solutions, acids, bases, detergents, sodium deoxycholate,polidocanol, sodium docecyl sulfate, and hypertonic saline) in thecavity of the tissue plane formed by the lysing action of the invention.If acids or bases are used to deliberately traumatize tissue to inducefibrosis then they may be neutralized by their opposing party forexample an acid solution induces trauma and is neutralized by a dilutesodium bicarbonate lavage. Non-solutions that can irritate orcontrollably traumatize human tissues into a fibroblast/collagenresponse could include, but should not be limited to, silicone/salinesuspensions, collagen suspensions, fat globule/oil water suspension,sand, glass, carbon and carbonized organic matter, plastic granules,other insoluble granules, soaps, ground microbiological, plant or animalmatter. Such materials would cause a microgranulomatous response withcollagen/fibroblast proliferation. Plastic or pressure resistant tubesor tubules on the order of 0.01 cm to 1 cm may transmit prolotherapyagents via the inert or insulated tubing to the prolotherapy emittingembodiment of the planar-tissue-altering-window/zone. Said tubules mayterminate in small spray nozzles in other embodiments to allow spraydistribution of prolotherapy agents onto the target surfaces. In theprolotherapy embodiment, prolotherapy agents or other tissue alteringmedicines are made ready in an IV bag or other reservoir located outsidethe shaft and gated nearby there. Gravitational progression of fluidsfrom IV bags may be sufficient to distribute the prolotherapy agentsthrough several meters of IV tubing through the shaft onto the“window/zone.” For drip or spray distributions, the prolotherapy agentmay be forced on its passage from the reservoir by numerous methodsknown in the art including but not limited to peristaltic pump,pressurized gas instillation, powered injection system and apressurize-able reservoir. Flow rates and pressure rates may varydepending upon the concentration, volume, desired tissue contractiontime and type of agent applied and may vary from 0.01 cc to 10 cc perminute. Footswitch control or voice activated control (in addition tooptional thermal sensor/CPU feedback loops) of fluid release would allowconvenience since the operating surgeon's hand may be occupied withdevice motion or activation of the lysing function of the device.

Planar-tissue-altering-window/zone embodiments for Uniform HeatingElements may be constructed by incorporating uniform tissue heatingelements on one side of the proximal tip connected to an insulatedconductive element passing through the shaft that are controllablyelectrified at handle in a fashion independent from the radiofrequencyelements in the lysing segments. Thermal sensors nearby monitor tissuetemperatures in order to create feedback or audible output to thesurgeon or a computer so as to controllably apportion energy to thetarget tissues. This loop may thus controllably restrict thermal tissuedamage and optimize contraction results. The thermal sensors may be ofan infrared type, optical fiber type, an electronic type, or opticalfluorescence type, each being known in the prior art and thus a detaileddescription thereof is deemed unnecessary.

Planar-tissue-altering-window/zone for a Thermal Energized embodimentallows thermal energy to escape from within the shaft where tip can beintegral or a continuation of shaft made of similar metal or materials.The tip may also be constructed of materials that are both electricallynon-conductive and of low thermal conductivity; such materials might beporcelain, ceramics or plastics. Portions of the tip and shaft may becovered with Teflon® to facilitate smooth movement of the device underthe skin. A hot filament within the device is heated by flowing currentthrough connecting wires and is held rigidly in position within aparabolic cavity by the strength of the wire. Alternately, the filamentis fixedly attached to the shaft. The hot filament emits optical andthermal radiation that can directly exit theplanar-tissue-altering-window/zone or be reflected off a reflector toalso exit through window. The reflector can have a parabolic shape toeffectively collect all optical and thermal radiation emitted away fromthe window. The hot filament can be a tungsten carbide filament similarto those used in high power light bulbs. The wavelength may be adjustedand controlled by adjusting the filament temperature/current. The windowcan be selected from a wide variety of glass that transmits optical,near infrared and infrared light (e.g., quartz, fused silica andgermanium.) The tissue penetration depth depends on the wavelength ofthe light (e.g., 1 μm penetrates through 10 mm, 10 μm penetrates through0.02 mm). The broad emission spectrum from the hot filament can befiltered to achieve the desired tissue effect. In particular filteringthe emission spectrum to heat the dermis to temperatures ofapproximately 70° C. will cause the desired collagen shrinkage andtightening. The optimum spectral filtering depends on skin thickness andstructure. A thermal sensors connected to the control unit by electricalwire monitors the temperature of tissue that is in contact with theshaft. In order to eliminate excessive heating of the shaft and thesurrounding facial tissue, a heating element and reflector are thermallyisolated by low thermal conductivity materials. The element is isolatedby not touching the shaft, whereas the reflector can have an isolatinglayer where it attaches to the shaft. In addition, cold nitrogen gas canbe injected through tube and pumped out through the hollow shaft to coolthe tip and shaft. Flowing nitrogen gas (or another inert gas) throughthe hollow shaft also reduces oxidation damage to the filament. Analternative embodiment in co-pending applications places the hotfilament in the handle while emitted optical and thermal radiation isreflected off a mirror through the window. An alternative embodiment inco-pending applications allows tissue heating is achieved by the directcontact with a hot surface where electric current flowing through wiresheats a resistive load made of single or multiple elements to a userselected temperature. The resistive load could be a thin film resistorand the film temperature could be estimated from the measuredresistance. Alternatively, separate thermal sensors placed close to theheating element measure temperatures, which are sent to a control unitto control the current through the resistive load. Cold gas or liquidcan be injected through tubes and pumped out through the shaft. Also,the heating element could be the hot side of a Peltier thermoelectriccooler, which advantageously cools the opposite surface below ambienttemperature with differences of up to 40° C. Thermal embodiments whereinheat is derived via magnetic or frictional methods may bring aboutsimilar tissue alterations.

In all embodiments of the device, the shaft can be coated with abiocompatible non-stick material such as Teflon® to reduce friction fromtissue sticking to the device during the procedure.

The present invention can also create well-defined limited or isolatedpockets in human tissue planes or locations for the implantation oforganic or inorganic implants. For example, operation of Applicant andapplicant's prior related art over a ‘weak’ cheekbone for an areamimicking the shape of the underlying cheekbone, and the additionaldesired look, yields a pocket into which the organic or inorganicimplantable liquids or semisolids may be injected. Current implantablematerials include but are not limited to: Absorbable suture materialPolyglactic acid (Vicryl®, Polysorb®), Polyglycolic acid (Dexon®),Polydioxanone (PDS II®), Glycolic acid (Maxon®), Poliglecaprone 25(Monocryl®), Glycoer 631 (Biosyn®), Surgical gut (plain), Surgical gut(chromic), Surgical gut (fast-absorbing). Nonabsorbable Suture material:Nylon (Ethilon®, Dermalon®, Nurulon®, Surgilon®)—braided or unbraided

Polypropylene (Prolene®, Surgilene®, Surgipro®), Silk, Polyester(Dacron®, Mersilene®, Ethibond®), Polybutester (Novafil®), SurgicalStainless Steel®. Grafts/Meshes including but not limited to: Expandedpolytetrafluoroethylene (ePTFE) (Gore-Tex®, SoftForm®), Polyethylene(Dacron®), Polypropylene (Prolene®, Marlex®), Polyglactin (Vicryl®,Dexon®), Polyethylene terephthalate (Mersilene®),Polypropylene/polyglactin (Vypro®), Alloderm®, Sepramesh® (polypropylenemesh coated on one side with sodium hyaluronate andcarboxymethylcellulose), Seprafilm® (sodium hyaluronate andcarboxymethylcellulose), Silicone, PROCEED® Surgical Mesh, ULTRAPRO®Partially Absorbable Lightweight Mesh Surgical Titanium Mesh®.Miscellaneous materials including but not limited to: Bovine collagen(Zyderm® collagen I, Zyderm® collagen II, Zyplast®), Human-derivedcollagen (Deramologen®, Cymetra®), Cadaveric fascia lata (Fascian®),Porcine collagen, Hyaluronic acid derivatives (Restylane®, Hylaform®,Hylan B® gel, Perlane®), Alloderm® (acellular allograft dermal matrix),Polyethylene terephthalate (Mersilene®), Proplast®, Medpor®, Titaniummetal alloy, Vitallium metal alloy, Silicone, Hydroxyapatite, Bioglass,and Nonceramic hydroxyapatite.

For decades plastic surgeons have inserted biological andnon-biological, organic and inorganic meshes into the face to remedydefects and lend support, and other areas such as the abdomen and grointo lend support and to hold back herniated tissues. However, placementof the meshes necessitated much larger surgical openings than would benecessary with applicant and co-pending which are uniquely able to allowlarge potential free surface areas for mesh to be implanted upon whilefitting such large meshes through only minimally invasive incisions.Meshes can be made of: body-reactive organic substances including cottonand silk; body-inert organic substances such as plastics, polypropyleneor Gore-Tex® (low density polyethylene); materials in-between, forexample, nylon is minimally reactive; inorganic substances such asstainless steel or other metals and silicone. Meshes can be unfolded orunrolled after insertion through the minimally invasive entrance woundsto occupy any or all of the tissue planes that were separated. Meshescan be fashioned to extend in the upper neck to extend almost fromearlobe to earlobe to act as a sling when stitch secured into place. Onthe other hand, mesh fixation can be delayed or allowed to heal (orfibrose=collagen form) into place over several months before reopeningsmall portions of the tissue planes containing the supportive mesh forvectored stitch tightening. Deposited meshes can be sewn immediately tocreate tension and/or support. Location and proper unraveling of meshescan be determined by endoscope or by portable x-ray via radio-opaquepaint or lacing with metals or elements or compounds. Meshes can be made“stickier” to incoming collagen and fibrous tissues by sandblasting,rasping or chemically altering the material prior to sterilization. Thesurgical device can also be used to deposit well-defined implants suchas “cheekbone” type in a minimally invasive manner or fluid, semisolidor other implants with less definitions. Depending upon the need forsuspension of lax or prolapsed tissues, nets, meshes or slings ofbiologically compatible organic or inorganic materials such as thefollowing may be implanted for immediate suture fixation or tightening.Alternatively, biocompatible materials may be allowed to “heal in place”so as to strengthen the underlying tissues for a later or delayedsurgical procedure. The following list of potential implantablebioabsorbable and nonabsorbable materials is not exhaustive and notintended to be limiting: polyglactic acid, polyglycolic acid,polydioxanone, glycolic acid, poliglecaprone 25, glycoer 631, nylon,polypropylene, silk, cotton, polyester, polybutester, surgical Stainlesssteel, expanded polytetrafluoroethylene (ePTFE), polyethylene,polyglactin, polyethylene, terephthalate, Dacron®, Alloderm®, Sepramesh®(polypropylene mesh coated on one side with sodium hyaluronate andcarboxymethylcellulose), Seprafilm® (sodium hyaluronate andcarboxymethylcellulose), silicone, PROCEED® Surgical Mesh, ULTRAPRO®Partially Absorbable Lightweight Mesh, Surgical Titanium Mesh®, bovineor human or porcine-derived collagen, cadaveric fascia lata (Fascian®),hyaluronic acid derivatives, Alloderm® (acellular allograft dermalmatrix), polyethylene terephthalate (Mersilene®), Proplast®, Medpor®,titanium metal alloy, vitallium metal alloy, hydroxyapatite, bioglass,and nonceramic hydroxyapatite. For example, a Gore-tex® sling may bestrung through minimal incisions into the large underlying lysed planeusing typical surgical instrumentation such as forceps, hooks, clampsand malleable guide-wires between the fibrous tissues and under the neckfrom the right to the left mastoid regions if the incisions are locatedin the infraauricular regions. Meshes may be unrolled once fed into thelysed facial planes through the minimal incision sites and maneuveredinto place via probes or instruments placed in any of the incisionsites; proper seating of the mesh may be detected endoscopically,fiberoptically, and ultrasonographically. If metal tags such as metallicthread are laced intermittently to the edge of the mesh thenradiological evaluation is possible especially if the mesh is itself iscomprised of, or attached to, any radio-opaque biocompatible material.Meshes on small <2 cm wide but <1 cm thick rollers fitted with a loose<6 cm wire or monofilamentous plastic loops passing through the centerof the “roller” may be fed into incision sites and received with aprobe, instrument or malleable hook to unroll the mesh in varyingdirections using other incision sites. Alternatively, the device may beused in a more limited fashion to create precise, isolated, uniformtissue pockets at tissue plane levels chosen by the surgeon over suchareas such as the malar eminences (cheekbones) so standard implants maybe fed through the device entrance incisions, with some scalpelexpansion of the entrance wounds or from some other location, forexample, intraoral. Precise pockets may be created to receivebiocompatible thermosetting or time setting or reactant setting softfoam that is restricted to the shape of the instrument-created pocketand can be finger sculpted or template sculpted by applying pressureduring setting. Following any of the above measures, two absorbableburied 5-0 Monocryl® (Ethicon division of Johnson & Johnson, Piscataway,N.J.) stitches are placed in each incision. A dressing is usually notneeded and the patient may return to work or relax at home.Alternatively, if significant prolotherapy or implantable material isplaced a loose floss-filament dressing may be applied around the facefor 24 to 48 hours. If the patient is prone to swelling or bleeding, asmall Jackson-Pratt drain may be placed through any incision site andsutured into place underneath the dressing.

Planning obsolescence is integral to maintaining proper performance andquality of a device over time. Interposed among, along or betweensegments of either the circuitry and/or the fiberoptics of theaforementioned embodiments may be hardware or software on for example acard or a chip. The card or chip or other usage monitoring subdevice maybe inserted into a receiving area in such a place as the handle oradjacent the electrosurgical generator; it can either record dataincluding but not limited to time usage of, cutting current, coagulationcurrent or blend value. The subdevice, interposed into the circuitry,fiberoptics or other energy delivery mechanisms can terminate thefunctions of the device unless some type of criteria is met forreactivation. Criteria might be obtaining a password, new card or chipfollowing a payment. This and other plans for metered, monitored orrestricted usage that are currently known in the art may be used inconjunction with embodiments presented.

Operative Procedure: Following informed consent and having been free ofeating or drinking for 12 hours, the patient is placed in the supineposition. The face and neck are cleansed with standard preoperativecleansers such as iodine or chlorhexidine. Minimal incision sites of 1cm are marked at any position along the preauricular or infraauricularline at the surgeon's discretion. Further 1 cm minimal incision sitesare marked with a surgical marker in areas that may include thesubmental (below the chin) zone in order to reach the neck and possiblyin the superiormost forehead within the hairline in order to disguisethe incision. The small zones of skin overlying the regions where themotor nerves at risk (marginal mandibular nerve, frontal branch of thefacial nerve, spinal accessory nerve) are demarcated with dashed linesof surgical marker. By this point, the patient has chosen the option ofbeing twilight-sedated intravenously or given general anesthesia byendotracheal tube or LMA (laryngeal mask airway) although most patientsdo not require any of these measures to endure the remainder of theprocedure. The surgically marked incision sites are further cleansed andthen injected with only 1 cc of 1% lidocaine with 1:100,000 epinephrineeach and allowed to settle for 3 minutes. Each area is incised with a#15 scalpel blade through the epidermis and dermis into the subcutaneouslayer; the forehead site should be incised parallel to the hairfollicles to prevent baldness in the area. 1 liter of Klein tumescentsolution is prepared with the following recipe: 1 liter of normal salineinto which is mixed, 40 cc of 2% lidocaine and 10 cc of 10 mEq/L ofNaHCO₃ and 1:1,000 epinephrine. Only 50 cc to 200 cc of the Kleintumescent solution is rapidly peristaltically pumped into areasreachable by each incision site into the subcutaneous layer using aspinal needle or a 2 mm wedge-tipped or spatula-tipped fluidinstillation catheter in a fanning motion similar to the vectors whichwill ultimately be the directions of later passage for the facialtightening device. After the few minutes needed for Klein tumescentinstillation, the Klein solution is allowed to settle for 15 minutes formaximum effect. One of the selected device embodiments described hereinis maintained sterile and is attached to one or more electrosurgicalgenerators or lasers or other energy form generators. Prior to using anelectrosurgical window/zone embodiment, set the electrosurgicalgenerator to the appropriate cut and coagulation settings. The chosendevice is inserted into one the incision sites while being held firmlyat the handle and pushed forcefully axially while lifting occurs.Motion, while the device is activated by footswitch or handle rocker oractivating button, is commenced along straight lines radiating from theincision sites in a spoke-wheel fashion as far as possible usuallywithout entering the eyelid region or the lips or the demarcated zonesof superficial motor nerves. Depending upon the quality of tissue beinglysed, patient age, prior facial surgery history, medical history,physical examination, patient demographics, the tissueplanar-tissue-altering-window/zone may be activated “face up” toenergize the dermis or “face down” to energize the subcutaneous whichwill leak fatty acids and draw inflammatory cells and mediators which inturn stimulate the opposing dermal layer fibroblasts to manufacturecollagen; a combination of “face up” and “face down” can also be used.Traumatizing the underlying subcutaneous tissue or “cooking the fat,”causes inflammation in the subcutaneous layer which transfers toover-draping dermal flap causing dermal inflammation and thuscontraction (unpublished, preparing manuscript to be submitted tomedical journal). Likewise, traumatizing underlying muscle (in this casethe platysma muscle that envelopes most of the front of the neck) tocause char or other debris, may cause a similar contractile response inthe platysma and the over-draping dermal skin flap. The formation ofcarbon and carbonized organic chemicals (matter) likely inducesinflammation via several pathways including: bringing macrophages whichhave to envelope and digest the material and by inducing leakage ofcellular mediators which inflammatory cell gatherings and theirresultant tissue cascade and tissue modifications. Additionally, energyapplication from the planar-tissue-altering-window/zone may occur onwithdrawal portion of the stroke as opposed to the thrust portion. Thethrust portion may or may not provide the most cool environment to thewindow/zone which may vary with the energy level associated with theelectrosurgical tissue lysing element. External cooling devices may beapplied to the facial skin before, during or after treatment, forexample, ice cool water soaked towels or ice cold water circulatedthrough a externally conforming bag to enhance the reverse thermalgradient. Depending upon numerous factors including the energy type andamount used, additional lysed tissue plane modification may be neededusing prolotherapy solutions which may be injected via canals containedin or along the shaft or by a separate catheter mechanism. Such asolution as 250 cc of 25% NaCl (hypertonic saline) may be instilled intothe freshly cleaved facial interplane space following activatedinstrument passage, massaged or allowed to sit for 10 minutes and thenpressed out through the incision sites and then neutralized with 2flushes of normal saline instilled in a separate catheter system, whichinstilled the tumescent solution, which is then pressed out through thesame incision sites. Prolotherapy agents known in the art to enhancetissue fibrosis and collagenization of the human joints includesclerosing or proliferative solutions such as hypertonic glucose(D-glucose), sodium morrhuate, and phenol. Fibrosis-inducing chemicalsor mixtures in liquid, foam, suspension, powder, or any other form knownto possess the ability to stimulate fibroblasts or increasecollagenization (including but not limited to sodium deoxycholate,polidocanol, sodium docecyl sulfate) may be instilled similarly to thepreviously described 25% NaCl. If acids or bases are used todeliberately traumatize tissue to induce fibrosis then they may beneutralized by their opposing party for example an acid solution inducestrauma and is neutralized by a dilute sodium bicarbonate lavage.

A potential benefit of beard and neck region of using either the passageof the energized relative recession or the tissue-altering-window/zoneis that hair loss will occur with standard settings in males, becausethe design uniquely places the cutting segment at the lower level of thehair bulbs which causes destruction of the hair bulb. Regrowth isusually impeded following said trauma.

The foregoing description of preferred embodiments and methods of use ofthe invention are presented for purposes of illustration and descriptionand are not intended to be exhaustive or to limit the invention to theprecise form disclosed. Many modifications and variations are possiblein light of the above teaching. The embodiments were chosen anddescribed to best explain the principles of the invention and itspractical application to thereby enable others skilled in the art tobest use the invention in various embodiments and with variousmodifications suited to the particular use contemplated.

1. An apparatus for performing a medical procedure, comprising: a shafthaving a proximal end and a distal end; and at least one recessionpositioned at the distal end, wherein the at least one recessionseparates tissue into first and second tissue planes, and wherein theapparatus maintains the tissue planes in a configuration such that thefirst tissue plane is substantially parallel to the second tissue planeas the apparatus is pushed through the tissue at the distal end.
 2. Theapparatus of claim 1, wherein the at least one recession comprises ameans for delivering energy.
 3. The apparatus of claim 2, wherein themeans for delivering energy comprises at least one of laser energy,radiofrequency electrosurgical current, and electromagnetic energy. 4.The apparatus of claim 1, wherein said shaft comprises a firstsubstantially planar surface and a second substantially planar surface,wherein the first substantially planar surface is substantially parallelto the second substantially planar surface.
 5. The apparatus of claim 1,further comprising a plurality of protruding members, wherein the atleast one recession is positioned in between at least two protrudingmembers.
 6. The apparatus of claim 1, further comprising an energydelivery area positioned on said shaft for delivering energy to asurface of tissue created by separating the tissue into the tissueplanes.
 7. The apparatus of claim 6, wherein the energy delivery areadelivers at least one of electrical energy, thermal energy,electromagnetic energy, and chemical energy.
 8. The apparatus of claim6, wherein the energy delivery area comprises an array of individualenergy delivery elements.
 9. The apparatus of claim 8, wherein the arrayof energy delivery elements alters tissue at each of a plurality oftissue locations with less relative tissue alteration between each saidtissue location.